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uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer

Primary Purpose

Oral Cancer, Oropharyngeal Cancer, Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
68Ga-NOTA-AE105 PET/CT
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Oral Cancer focused on measuring Uroplasminogen Plasminogen Activator Receptor, Oropharyngeal cancer, oral cancer, Positron Emission Tomography

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to understand patient information and to give informed consent
  • Not previously irradiated or operated on neck
  • Operable disease

Study I OSCC cN0 verified histologically by pathologic examination of biopsy

Study II OSCC or OPSCC N + verified histologically by pathologic examination of biopsy

Exclusion Criteria:

  • Pregnancy
  • Patients who are candidates for curative intentional radiation
  • Patients who have had surgery or radiation therapy to the neck as this may alter the lymph drainage.
  • Other diseases assessed by the investigator as basis for exclusion.
  • Age under 18 or over 85 years
  • Obesity> 140 kg
  • Allergy to 68Ga-NOTA-AE105

Sites / Locations

  • Department of Clinical Physiology, Nuclear Medicine and PET, RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-NOTA-AE105 PET/CT

Arm Description

One injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before surgery and compared with the histological findings to evaluate uPAR PET/CT in staging of oral cancer and oropharyngeal cancer.

Outcomes

Primary Outcome Measures

The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.

Secondary Outcome Measures

Evaluation of the correlation between uPAR PET signal (quantified as SUVmax) and the immunohistochemical expression of uPAR evaluated by an H-score (intensity x the percentage of stained tumor tissues throughout the tumor margin).
Evaluation of the correlation between tumor burden (assessed v.h.a. TNM staging) uPAR-PET signal (assessed as SUVmax) and the amount of uPAR metabolites in plasma.
Determination of the lower detection limit of the amount of tumor tissue for uPAR-PET correlated with the histological H-score x tumor size (where tumor size is evaluated on the pathological preparation of pathologist)

Full Information

First Posted
October 11, 2016
Last Updated
November 7, 2016
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02960724
Brief Title
uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
Official Title
Phase II Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer
Detailed Description
To compare the diagnostic value of uPAR-PET/CT for prognostication compared to the current imaging options (CT, MRI and ultrasound) by observer-blinded readings. The reference that will be used as "gold standard" is the pathological examination of the surgically removed tissues. The new imaging modality (uPAR-PET/CT) will be used in two separate groups of patients with head and neck cancer: Study I: Patients with oral cancer without clinical evidence of spread (OSCC in stage cN0) Study II: Patients with metastatic oral cancer (OSCC in stage cN +) and patients with metastatic oropharyngeal cancer (OPSCC in stage cN +).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer, Oropharyngeal Cancer, Neoplasms, Head and Neck Neoplasms, Cancer of Mouth, Neoplasms by Site
Keywords
Uroplasminogen Plasminogen Activator Receptor, Oropharyngeal cancer, oral cancer, Positron Emission Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-NOTA-AE105 PET/CT
Arm Type
Experimental
Arm Description
One injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before surgery and compared with the histological findings to evaluate uPAR PET/CT in staging of oral cancer and oropharyngeal cancer.
Intervention Type
Other
Intervention Name(s)
68Ga-NOTA-AE105 PET/CT
Intervention Description
One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.
Primary Outcome Measure Information:
Title
The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.
Time Frame
Through study completion, an average of 1.5 year
Secondary Outcome Measure Information:
Title
Evaluation of the correlation between uPAR PET signal (quantified as SUVmax) and the immunohistochemical expression of uPAR evaluated by an H-score (intensity x the percentage of stained tumor tissues throughout the tumor margin).
Time Frame
Through study completion, an average of 1.5 year
Title
Evaluation of the correlation between tumor burden (assessed v.h.a. TNM staging) uPAR-PET signal (assessed as SUVmax) and the amount of uPAR metabolites in plasma.
Time Frame
Through study completion, an average of 1.5 year
Title
Determination of the lower detection limit of the amount of tumor tissue for uPAR-PET correlated with the histological H-score x tumor size (where tumor size is evaluated on the pathological preparation of pathologist)
Time Frame
Through study completion, an average of 1.5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to understand patient information and to give informed consent Not previously irradiated or operated on neck Operable disease Study I OSCC cN0 verified histologically by pathologic examination of biopsy Study II OSCC or OPSCC N + verified histologically by pathologic examination of biopsy Exclusion Criteria: Pregnancy Patients who are candidates for curative intentional radiation Patients who have had surgery or radiation therapy to the neck as this may alter the lymph drainage. Other diseases assessed by the investigator as basis for exclusion. Age under 18 or over 85 years Obesity> 140 kg Allergy to 68Ga-NOTA-AE105
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Kjær, MD,DMSc,PhD
Organizational Affiliation
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Official's Role
Study Director
Facility Information:
Facility Name
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirstine KS Karnovs, MD
Phone
+4526227128
Email
Kirstine.kim.schmidt.karnov@regionh.dk
First Name & Middle Initial & Last Name & Degree
Andreas Kjær, MD,DMSc,PhD
Phone
+4535454011
Email
akjaer@sund.ku.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27609788
Citation
Skovgaard D, Persson M, Brandt-Larsen M, Christensen C, Madsen J, Klausen TL, Holm S, Andersen FL, Loft A, Berthelsen AK, Pappot H, Brasso K, Kroman N, Hojgaard L, Kjaer A. Safety, Dosimetry, and Tumor Detection Ability of 68Ga-NOTA-AE105: First-in-Human Study of a Novel Radioligand for uPAR PET Imaging. J Nucl Med. 2017 Mar;58(3):379-386. doi: 10.2967/jnumed.116.178970. Epub 2016 Sep 8.
Results Reference
result
PubMed Identifier
26516369
Citation
Persson M, Skovgaard D, Brandt-Larsen M, Christensen C, Madsen J, Nielsen CH, Thurison T, Klausen TL, Holm S, Loft A, Berthelsen AK, Ploug M, Pappot H, Brasso K, Kroman N, Hojgaard L, Kjaer A. First-in-human uPAR PET: Imaging of Cancer Aggressiveness. Theranostics. 2015 Sep 13;5(12):1303-16. doi: 10.7150/thno.12956. eCollection 2015.
Results Reference
result
PubMed Identifier
26429955
Citation
Persson M, Nedergaard MK, Brandt-Larsen M, Skovgaard D, Jorgensen JT, Michaelsen SR, Madsen J, Lassen U, Poulsen HS, Kjaer A. Urokinase-Type Plasminogen Activator Receptor as a Potential PET Biomarker in Glioblastoma. J Nucl Med. 2016 Feb;57(2):272-8. doi: 10.2967/jnumed.115.161703. Epub 2015 Oct 1.
Results Reference
result

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uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer

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