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A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

Primary Purpose

Head and Neck Cancer, Unknown Primary Cancer, Head and Neck Squamous Cell Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pegsitacianine
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults ≥18 years of age
  2. Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator)

    1. Part 1: Stage 1 to 4 HNSCC
    2. Part 2: UPC squamous cell carcinoma of the head and neck with metastatic disease to at least a single cervical node, AND no biopsy proven evidence of the primary cancer's location.
  3. Acceptable hematologic status (as standard surgery protocol requires, as determined by the Investigator), kidney function and liver function. Elevations of creatinine, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin >1.5× the upper limit of normal [ULN] must be determined to be not clinically significant by the Investigator and approved by the Medical Monitor.
  4. Documented negative serum pregnancy test for women of childbearing potential (i.e., premenopausal women with intact reproductive organs and women <2 years after menopause)
  5. Male patients and female patients of child-bearing potential (i.e., premenopausal women with intact reproductive organs and women <2 years after menopause) must agree to and comply with using medically acceptable contraception including surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation), intrauterine device, oral contraceptive, contraceptive patch, long acting injectable contraceptive, partner's vasectomy, double-barrier method (condom or diaphragm plus spermicide or condom plus diaphragm), or abstinence during the trial and for 6 months thereafter
  6. Agree to abstain from alcohol consumption from 72 hours before Pegsitacianine administration through completion of Study Day 10 (±48 hours) visit in Part 1 and Part 2.
  7. Adequate potential for follow up

Exclusion Criteria:

  1. Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible.
  2. Life expectancy <12 weeks
  3. Karnofsky Performance Status <70%
  4. Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis
  5. Lab values or any sign, symptom, or medical condition that in the opinion of the PI would prevent surgical resection
  6. Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
  7. Pregnant or lactating women
  8. Receiving or planned to receive, during the duration of the study, concomitant medication with a high chance of hepatotoxicity, as judged by the PI based on standard protocols within the study center
  9. Alcohol consumption within 72 hours before Pegsitacianine administration
  10. Received an investigational agent within the shorter of 5 half-lives or 30 days before Pegsitacianine dosing
  11. Inability to adhere to the schedule of assessments or any circumstance that would interfere with the validity of assessments performed in the study
  12. The PI considers that the patient should not participate in the study

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Part 1 - Cohort A

Part 2 - Cohort B

Arm Description

In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-100 hours prior to surgery will be used to image primary tumors in patients with HNSCC to evaluated to verify the diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes.

In Part 2, pegsitacianine the single dose of 1 mg/kg of given 6-100 hours prior to surgery will be used to in patients with unknown primary cancer of the head and neck. These patients typically undergo exam under anesthesia with a laryngoscopy as well as panendoscopy for identifying the source of the metastatic cancer found in the cervical nodes. The diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes in these patients will be evaluated. All the available data to date will be used to decide the additional tumor type(s), number of patients per tumor type, and number of Group(s) to be enrolled.

Outcomes

Primary Outcome Measures

Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with HNSCC
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Patient safety will be assessed for 10 days (±48 hours) post dose. All patients will be monitored for vital signs and physical examination pretreatment and at various time points up to Day 6 (±24 hours). All patients will be monitored for comprehensive metabolic panel (CMP) and complete blood count (CBC) with differentials pretreatment and at various time points up to Day 10 (±48 hours). All patients will be monitored for TEAEs, and concomitant medication use from the start of dosing up to Day 10 (±48 hours). TEAEs will be followed closely during the study to identify any potential DLTs
Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with UPC
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Patient safety will be assessed for 10 days (±48 hours). All patients will be monitored for vital signs and physical examination pretreatment and at various time points up to Day 6 (±48 hours). All patients will be monitored for comprehensive metabolic panel (CMP) and complete blood count (CBC) with differentials pretreatment and at various time points up to Day 10 (±48 hours). All patients will be monitored for TEAEs, and concomitant medication use from the start of dosing up to Day 10 (±48 hours). TEAEs will be followed closely during the study to identify any potential DLTs

Secondary Outcome Measures

Pegsitacianine fluorescence imaging in HNSCC, UPC primary cancers that are HPV positive and HPV negative
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Assessment of use of Pegsitacianine for intra-operative imaging of HNSCC, UPC and metastatic lymph nodes will include quantification of intraoperative and postoperative fluorescence signals from histology confirmed tumor and normal tissues, calculation of TBR and diagnostic performance. Feasibility determination will be based on a combined assessment of intraoperative in vivo and ex vivo fluorescent signals together with ex vivo examinations (histological examination, NIR flatbed scanning).

Full Information

First Posted
October 5, 2022
Last Updated
October 14, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05576974
Brief Title
A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)
Official Title
A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
Detailed Description
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent. The main purpose of this study is to investigate whether Pegsitacianine can be used to image head and neck cancers as well as unknown primary cancer of the head and neck 6-100 hours post dose in patients undergoing routine surgery for biopsy, evaluation, detection or removal of their primary cancer. The study consists of two Parts. Part 1 will be performed in a single dose of 1 mg/kg given such that Pegsitacianine fluorescence can be used to image primary tumors in patients with HNSCC undergoing routine surgery at 6-100 hours, and if needed at an alternate imaging schedule post dose. Part 2 will be performed in a single dose of 1 mg/kg given such that Pegsitacianine fluorescence can be used to image primary tumors in patients with unknown primary cancer of the head and neck (UPC) at 6-100 hours, and if needed at an alternate imaging schedule post dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Unknown Primary Cancer, Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-100 hours prior to surgery will be used to image primary tumors in patients with HNSCC to evaluated to verify the diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes. In Part 2, pegsitacianine the single dose of 1 mg/kg of given 6-100 hours prior to surgery will be used to in patients with unknown primary cancer of the head and neck. These patients typically undergo exam under anesthesia with a laryngoscopy as well as panendoscopy for identifying the source of the metastatic cancer found in the cervical nodes. Subjects for Part 2 may begin dosing at any time during Part 1 thus the two parts can run concurrently.
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1 - Cohort A
Arm Type
Active Comparator
Arm Description
In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-100 hours prior to surgery will be used to image primary tumors in patients with HNSCC to evaluated to verify the diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes.
Arm Title
Part 2 - Cohort B
Arm Type
Active Comparator
Arm Description
In Part 2, pegsitacianine the single dose of 1 mg/kg of given 6-100 hours prior to surgery will be used to in patients with unknown primary cancer of the head and neck. These patients typically undergo exam under anesthesia with a laryngoscopy as well as panendoscopy for identifying the source of the metastatic cancer found in the cervical nodes. The diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes in these patients will be evaluated. All the available data to date will be used to decide the additional tumor type(s), number of patients per tumor type, and number of Group(s) to be enrolled.
Intervention Type
Drug
Intervention Name(s)
Pegsitacianine
Intervention Description
Infusion of the Pegsitacianine-Intraoperative fluorescence imaging
Primary Outcome Measure Information:
Title
Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with HNSCC
Description
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Patient safety will be assessed for 10 days (±48 hours) post dose. All patients will be monitored for vital signs and physical examination pretreatment and at various time points up to Day 6 (±24 hours). All patients will be monitored for comprehensive metabolic panel (CMP) and complete blood count (CBC) with differentials pretreatment and at various time points up to Day 10 (±48 hours). All patients will be monitored for TEAEs, and concomitant medication use from the start of dosing up to Day 10 (±48 hours). TEAEs will be followed closely during the study to identify any potential DLTs
Time Frame
5 years
Title
Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with UPC
Description
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Patient safety will be assessed for 10 days (±48 hours). All patients will be monitored for vital signs and physical examination pretreatment and at various time points up to Day 6 (±48 hours). All patients will be monitored for comprehensive metabolic panel (CMP) and complete blood count (CBC) with differentials pretreatment and at various time points up to Day 10 (±48 hours). All patients will be monitored for TEAEs, and concomitant medication use from the start of dosing up to Day 10 (±48 hours). TEAEs will be followed closely during the study to identify any potential DLTs
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Pegsitacianine fluorescence imaging in HNSCC, UPC primary cancers that are HPV positive and HPV negative
Description
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Assessment of use of Pegsitacianine for intra-operative imaging of HNSCC, UPC and metastatic lymph nodes will include quantification of intraoperative and postoperative fluorescence signals from histology confirmed tumor and normal tissues, calculation of TBR and diagnostic performance. Feasibility determination will be based on a combined assessment of intraoperative in vivo and ex vivo fluorescent signals together with ex vivo examinations (histological examination, NIR flatbed scanning).
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults ≥18 years of age Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator) Part 1: Stage 1 to 4 HNSCC Part 2: UPC squamous cell carcinoma of the head and neck with metastatic disease to at least a single cervical node, AND no biopsy proven evidence of the primary cancer's location. Acceptable hematologic status (as standard surgery protocol requires, as determined by the Investigator), kidney function and liver function. Elevations of creatinine, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin >1.5× the upper limit of normal [ULN] must be determined to be not clinically significant by the Investigator and approved by the Medical Monitor. Documented negative serum pregnancy test for women of childbearing potential (i.e., premenopausal women with intact reproductive organs and women <2 years after menopause) Male patients and female patients of child-bearing potential (i.e., premenopausal women with intact reproductive organs and women <2 years after menopause) must agree to and comply with using medically acceptable contraception including surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation), intrauterine device, oral contraceptive, contraceptive patch, long acting injectable contraceptive, partner's vasectomy, double-barrier method (condom or diaphragm plus spermicide or condom plus diaphragm), or abstinence during the trial and for 6 months thereafter Agree to abstain from alcohol consumption from 72 hours before Pegsitacianine administration through completion of Study Day 10 (±48 hours) visit in Part 1 and Part 2. Adequate potential for follow up Exclusion Criteria: Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible. Life expectancy <12 weeks Karnofsky Performance Status <70% Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis Lab values or any sign, symptom, or medical condition that in the opinion of the PI would prevent surgical resection Medical or psychiatric conditions that compromise the patient's ability to give informed consent. Pregnant or lactating women Receiving or planned to receive, during the duration of the study, concomitant medication with a high chance of hepatotoxicity, as judged by the PI based on standard protocols within the study center Alcohol consumption within 72 hours before Pegsitacianine administration Received an investigational agent within the shorter of 5 half-lives or 30 days before Pegsitacianine dosing Inability to adhere to the schedule of assessments or any circumstance that would interfere with the validity of assessments performed in the study The PI considers that the patient should not participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baran Sumer, MD
Phone
2146482904
Email
Baran.Sumer@UTSouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Asha Varghese, MS
Phone
2146488096
Email
Asha.Varghese@utsouthwestern.edu
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Contact:
Phone
214-648-8096
Email
OTOresearch@utsouthwestern.edu
Phone
2146488096
Email
Asha.Varghese@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Baran Sumer, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25074731
Citation
Amit M, Yen TC, Liao CT, Chaturvedi P, Agarwal JP, Kowalski LP, Kohler HF, Ebrahimi A, Clark JR, Cernea CR, Brandao JS, Kreppel M, Zoller JE, Leider-Trejo L, Bachar G, Shpitzer T, Bolzoni AV, Patel RP, Jonnalagadda S, Robbins TK, Shah JP, Patel SG, Gil Z. The origin of regional failure in oral cavity squamous cell carcinoma with pathologically negative neck metastases. JAMA Otolaryngol Head Neck Surg. 2014 Dec;140(12):1130-7. doi: 10.1001/jamaoto.2014.1539.
Results Reference
background
PubMed Identifier
16473800
Citation
Dacosta RS, Wilson BC, Marcon NE. Spectroscopy and fluorescence in esophageal diseases. Best Pract Res Clin Gastroenterol. 2006 Feb;20(1):41-57. doi: 10.1016/j.bpg.2005.08.003.
Results Reference
background
PubMed Identifier
8378254
Citation
Davies B, Morris T. Physiological parameters in laboratory animals and humans. Pharm Res. 1993 Jul;10(7):1093-5. doi: 10.1023/a:1018943613122. No abstract available.
Results Reference
background
PubMed Identifier
24820548
Citation
Denaro N, Russi EG, Adamo V, Merlano MC. State-of-the-art and emerging treatment options in the management of head and neck cancer: news from 2013. Oncology. 2014;86(4):212-29. doi: 10.1159/000357712. Epub 2014 May 10.
Results Reference
background
PubMed Identifier
25890681
Citation
d'Alessandro AF, Pinto FR, Lin CS, Kulcsar MA, Cernea CR, Brandao LG, Matos LL. Oral cavity squamous cell carcinoma: factors related to occult lymph node metastasis. Braz J Otorhinolaryngol. 2015 May-Jun;81(3):248-54. doi: 10.1016/j.bjorl.2015.03.004. Epub 2015 Mar 30.
Results Reference
background
PubMed Identifier
25220842
Citation
Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
Results Reference
background
PubMed Identifier
20868625
Citation
Gioux S, Choi HS, Frangioni JV. Image-guided surgery using invisible near-infrared light: fundamentals of clinical translation. Mol Imaging. 2010 Oct;9(5):237-55.
Results Reference
background
PubMed Identifier
16540686
Citation
Haka AS, Volynskaya Z, Gardecki JA, Nazemi J, Lyons J, Hicks D, Fitzmaurice M, Dasari RR, Crowe JP, Feld MS. In vivo margin assessment during partial mastectomy breast surgery using raman spectroscopy. Cancer Res. 2006 Mar 15;66(6):3317-22. doi: 10.1158/0008-5472.CAN-05-2815.
Results Reference
background
PubMed Identifier
17448870
Citation
Jonkman A, Kaanders JH, Terhaard CH, Hoebers FJ, van den Ende PL, Wijers OB, Verhoef LC, de Jong MA, Leemans CR, Langendijk JA. Multicenter validation of recursive partitioning analysis classification for patients with squamous cell head and neck carcinoma treated with surgery and postoperative radiotherapy. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):119-25. doi: 10.1016/j.ijrobp.2006.12.002.
Results Reference
background
PubMed Identifier
16329134
Citation
Kim T, Giuliano AE, Lyman GH. Lymphatic mapping and sentinel lymph node biopsy in early-stage breast carcinoma: a metaanalysis. Cancer. 2006 Jan 1;106(1):4-16. doi: 10.1002/cncr.21568.
Results Reference
background
PubMed Identifier
30228269
Citation
Koller M, Qiu SQ, Linssen MD, Jansen L, Kelder W, de Vries J, Kruithof I, Zhang GJ, Robinson DJ, Nagengast WB, Jorritsma-Smit A, van der Vegt B, van Dam GM. Implementation and benchmarking of a novel analytical framework to clinically evaluate tumor-specific fluorescent tracers. Nat Commun. 2018 Sep 18;9(1):3739. doi: 10.1038/s41467-018-05727-y.
Results Reference
background
PubMed Identifier
20088598
Citation
Kumar R, Roy I, Ohulchanskky TY, Vathy LA, Bergey EJ, Sajjad M, Prasad PN. In vivo biodistribution and clearance studies using multimodal organically modified silica nanoparticles. ACS Nano. 2010 Feb 23;4(2):699-708. doi: 10.1021/nn901146y.
Results Reference
background
PubMed Identifier
27981971
Citation
Li Y, Zhao T, Wang C, Lin Z, Huang G, Sumer BD, Gao J. Erratum: Molecular basis of cooperativity in pH-triggered supramolecular self-assembly. Nat Commun. 2016 Dec 16;7:13777. doi: 10.1038/ncomms13777. No abstract available.
Results Reference
background
PubMed Identifier
25020134
Citation
Ma X, Wang Y, Zhao T, Li Y, Su LC, Wang Z, Huang G, Sumer BD, Gao J. Ultra-pH-sensitive nanoprobe library with broad pH tunability and fluorescence emissions. J Am Chem Soc. 2014 Aug 6;136(31):11085-92. doi: 10.1021/ja5053158. Epub 2014 Jul 29.
Results Reference
background
PubMed Identifier
24851630
Citation
Milenovic A, Virag M, Knezevic P, Boras VV, Ostovic KT, Panduric DG, Susic M. Evaluation of sentinel node biopsy in oral carcinomas. Coll Antropol. 2014 Mar;38(1):279-82.
Results Reference
background
PubMed Identifier
19817391
Citation
Mo J, Zheng W, Low JJ, Ng J, Ilancheran A, Huang Z. High wavenumber Raman spectroscopy for in vivo detection of cervical dysplasia. Anal Chem. 2009 Nov 1;81(21):8908-15. doi: 10.1021/ac9015159.
Results Reference
background
PubMed Identifier
26040238
Citation
Pedersen NJ, Jensen DH, Hedback N, Frendo M, Kiss K, Lelkaitis G, Mortensen J, Christensen A, Specht L, von Buchwald C. Staging of early lymph node metastases with the sentinel lymph node technique and predictive factors in T1/T2 oral cavity cancer: A retrospective single-center study. Head Neck. 2016 Apr;38 Suppl 1:E1033-40. doi: 10.1002/hed.24153. Epub 2015 Sep 2.
Results Reference
background
PubMed Identifier
26449839
Citation
Rosenthal EL, Warram JM, de Boer E, Basilion JP, Biel MA, Bogyo M, Bouvet M, Brigman BE, Colson YL, DeMeester SR, Gurtner GC, Ishizawa T, Jacobs PM, Keereweer S, Liao JC, Nguyen QT, Olson JM, Paulsen KD, Rieves D, Sumer BD, Tweedle MF, Vahrmeijer AL, Weichert JP, Wilson BC, Zenn MR, Zinn KR, van Dam GM. Successful Translation of Fluorescence Navigation During Oncologic Surgery: A Consensus Report. J Nucl Med. 2016 Jan;57(1):144-50. doi: 10.2967/jnumed.115.158915. Epub 2015 Oct 8.
Results Reference
background
PubMed Identifier
19170229
Citation
Schwarz RA, Gao W, Redden Weber C, Kurachi C, Lee JJ, El-Naggar AK, Richards-Kortum R, Gillenwater AM. Noninvasive evaluation of oral lesions using depth-sensitive optical spectroscopy. Cancer. 2009 Apr 15;115(8):1669-79. doi: 10.1002/cncr.24177.
Results Reference
background
PubMed Identifier
21039768
Citation
Sibille M, Patat A, Caplain H, Donazzolo Y. A safety grading scale to support dose escalation and define stopping rules for healthy subject first-entry-into-man studies: some points to consider from the French Club Phase I working group. Br J Clin Pharmacol. 2010 Nov;70(5):736-48. doi: 10.1111/j.1365-2125.2010.03741.x.
Results Reference
background
PubMed Identifier
23263205
Citation
Thompson CF, St John MA, Lawson G, Grogan T, Elashoff D, Mendelsohn AH. Diagnostic value of sentinel lymph node biopsy in head and neck cancer: a meta-analysis. Eur Arch Otorhinolaryngol. 2013 Jul;270(7):2115-22. doi: 10.1007/s00405-012-2320-0. Epub 2012 Dec 22.
Results Reference
background
PubMed Identifier
23881033
Citation
Vahrmeijer AL, Hutteman M, van der Vorst JR, van de Velde CJ, Frangioni JV. Image-guided cancer surgery using near-infrared fluorescence. Nat Rev Clin Oncol. 2013 Sep;10(9):507-18. doi: 10.1038/nrclinonc.2013.123. Epub 2013 Jul 23.
Results Reference
background
PubMed Identifier
24317187
Citation
Wang Y, Zhou K, Huang G, Hensley C, Huang X, Ma X, Zhao T, Sumer BD, DeBerardinis RJ, Gao J. A nanoparticle-based strategy for the imaging of a broad range of tumours by nonlinear amplification of microenvironment signals. Nat Mater. 2014 Feb;13(2):204-12. doi: 10.1038/nmat3819. Epub 2013 Dec 8.
Results Reference
background
PubMed Identifier
21833026
Citation
Webb BA, Chimenti M, Jacobson MP, Barber DL. Dysregulated pH: a perfect storm for cancer progression. Nat Rev Cancer. 2011 Aug 11;11(9):671-7. doi: 10.1038/nrc3110.
Results Reference
background
PubMed Identifier
28966871
Citation
Zhao T, Huang G, Li Y, Yang S, Ramezani S, Lin Z, Wang Y, Ma X, Zeng Z, Luo M, de Boer E, Xie XJ, Thibodeaux J, Brekken RA, Sun X, Sumer BD, Gao J. A Transistor-like pH Nanoprobe for Tumour Detection and Image-guided Surgery. Nat Biomed Eng. 2016;1:0006. doi: 10.1038/s41551-016-0006. Epub 2016 Dec 19.
Results Reference
background
Links:
URL
https://ctep.cancer.gov/protocoldevelopment/
Description
Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. National Cancer Institute 27NOV2017
URL
https://www.who.int/publications/journals/bulletin/
Description
Declaration of Helsinki
URL
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2
Description
ICH E6 (R2). Integrated addendum to ICH E6(R1): Guideline for good clinical practice. 09NOV2016
URL
http://www.fda.gov/downloads/drugs/guidances/ucm070107.Pdf
Description
FDA Bioanalytical Method Validation Guidance for Industry, May 2018
URL
https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=FoodSubstances
Description
EAFUS - Everything Added to Food in the United States. PEG: ASP, Doc#1285, CAS# 25322-68-3. Polymethacrylate: ASP, Doc# 1406, CAS# 54193-36-1

Learn more about this trial

A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

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