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Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors

Primary Purpose

Neuroendocrine Tumors

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

[68Ga]Pentixafor

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors focused on measuring 68Ga-pentixafor, (68Ga)pentixafor, Gallium Radioisotopes, CXCR4

Eligibility Criteria

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

Inclusion Criteria:

Age ≥ 18 years
Histological diagnosis of neuroendocrine tumor (NET).
Had a prior 68Ga DOTATATE PET/CT scan (NetSpot) and a CT or MRI with or without contrast performed within 3 months before signing the consent, without interval treatment other than a somatostatin analog.
CT or MRI must demonstrate at least one lesion (primary or metastatic) present 1.5 cm or larger in any dimension on cross-sectional imaging (CT or MRI) obtained within 3 months of study enrollment.
Results of CXCR4 immunohistochemistry or slides from biopsy of primary tumor or metastatic lesions available for study analysis.
Participation in the Iowa Neuroendocrine Tumor Registry.

Exclusion Criteria:

Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Physical limitation that would limit compliance with the study requirements
Pregnant or lactating women. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A negative pregnancy test will be required for all female subjects with child bearing potential.
Planned administration of any NET therapy between scan 1 and 2, except for Somatostatin analog.

Sites / Locations

Holden Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[68Ga]Pentixafor PET scan

Arm Description

4 mCi (range 3-5 mCi) of [68Ga]Pentixafor is administered intravenously over 1 minute using an infusion pump. PET imaging is performed from time of infusion for about 90 minutes. Approximately 12 blood samples (~ 1 tsp) will be taken for pharmacokinetic analysis.

Outcomes

Primary Outcome Measures

Determine biodistribution (pharmacokinetic parameters) of [68Ga]Pentixafor in patients with neuroendocrine tumors (NETs)

Biodistribution will be assessed through the radiotracer parameters standardized uptake value (SUV) and K-influx obtained from PET scan and blood samples.These values provide a pharmacokinetic profile of the investigational drug's biodistribution in the body.

Determine the repeatability of [68Ga]Pentixafor uptake in known neuroendocrine tumor lesions

Determine the difference, in any, of the biodistribution values between scans 1 and 2, for subjects who undergo 2 [68Ga]Pentixafor scans.

Secondary Outcome Measures

Compare standardized uptake values of [68Ga]Pentixafor and [68Ga]DOTATATE in known neuroendocrine tumor lesions

The standardized uptake value (SUV) of known neuroendocrine tumors for the investigational agent [68Ga]Pentixafor will be compared to the SUV for [68Ga]DOTATATE (NetSpot).

Correlate the uptake of [68Ga]Pentixafor and [68Ga]DOTATATE (NetSpot) in known neuroendocrine tumor lesions with expression of receptors (CXCR4 and SSTR2) in biopsy tissue samples.

The standardized uptake value (SUV) of the gallium PET tracers ( [68Ga]Pentixafor and/or [68Ga]DOTATATE) will be compared to the receptor expression score (H-score)

Full Information

NCT ID

NCT03335670

First Posted

October 12, 2017

Last Updated

September 15, 2022

Sponsor

Yusuf Menda

Collaborators

National Cancer Institute (NCI), National Institutes of Health (NIH), Holden Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03335670

Brief Title

Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors

Official Title

Biodistribution of Ga-68 Pentixafor in Patients With Neuroendocrine Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 3, 2017 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yusuf Menda

Collaborators

National Cancer Institute (NCI), National Institutes of Health (NIH), Holden Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will evaluate how Gallium-68 Pentixafor is distributed in neuroendocrine tumor patients and if that distribution is consistent through repeated scans. This is an RDRC study - as such, the images obtained for this study cannot be used clinically or shared with treating oncologists.

Detailed Description

High grade neuroendocrine tumors often do not express somatostatin (sstr) receptors but often express the CXCR4 receptor. The CXCR4 receptor is a marker of poorly differentiated cells. Pentixafor is a peptide that targets these CXCR4 receptors. By combining it with gallium-68, a radionuclide, pentixafor can then be evaluated as an imaging agent to detect high-grade neuroendocrine tumors. [68Ga]Pentixafor is a radio-labelled imaging agent used for positron emission tomography (PET). The dose is small, known as a tracer dose. It is designed to capture information about the body and how the body is working without interfering or causing an effect. The goal of this study is to evaluate how the [68Ga]Pentixafor is distributed through the body after injection and how it is taken up by the organs of the body. The study will also examine if the imaging is reproducible to determine if the PET images show the same uptake of the study drug across different scans. This study is an RDRC study - the equivalent to a phase 0 study. The [68Ga]Pentixafor has not been shown to target tumors; specificity and sensitivity have not been established. For this reason, images obtained for this study cannot be used clinically or shared with treating oncologists.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Tumors

Keywords

68Ga-pentixafor, (68Ga)pentixafor, Gallium Radioisotopes, CXCR4

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

[68Ga]Pentixafor PET scan

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

[68Ga]Pentixafor

Other Intervention Name(s)

(68Ga)pentixafor

Intervention Description

68Ga Pentixafor is a radiolabeled cyclic pentapeptide with high affinity for CXCR4 receptor

Primary Outcome Measure Information:

Title

Determine biodistribution (pharmacokinetic parameters) of [68Ga]Pentixafor in patients with neuroendocrine tumors (NETs)

Description

Time Frame

Within 1 month of [68Ga]Pentixafor scan

Title

Determine the repeatability of [68Ga]Pentixafor uptake in known neuroendocrine tumor lesions

Description

Determine the difference, in any, of the biodistribution values between scans 1 and 2, for subjects who undergo 2 [68Ga]Pentixafor scans.

Time Frame

Within 1 month of the second [68Ga]Pentixafor scan

Secondary Outcome Measure Information:

Title

Compare standardized uptake values of [68Ga]Pentixafor and [68Ga]DOTATATE in known neuroendocrine tumor lesions

Description

The standardized uptake value (SUV) of known neuroendocrine tumors for the investigational agent [68Ga]Pentixafor will be compared to the SUV for [68Ga]DOTATATE (NetSpot).

Time Frame

Within 6 months of [68Ga]Pentixafor scan

Title

Correlate the uptake of [68Ga]Pentixafor and [68Ga]DOTATATE (NetSpot) in known neuroendocrine tumor lesions with expression of receptors (CXCR4 and SSTR2) in biopsy tissue samples.

Description

The standardized uptake value (SUV) of the gallium PET tracers ( [68Ga]Pentixafor and/or [68Ga]DOTATATE) will be compared to the receptor expression score (H-score)

Time Frame

Within 6 months of [68Ga]Pentixafor scan

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years Histological diagnosis of neuroendocrine tumor (NET). Had a prior 68Ga DOTATATE PET/CT scan (NetSpot) and a CT or MRI with or without contrast performed within 3 months before signing the consent, without interval treatment other than a somatostatin analog. CT or MRI must demonstrate at least one lesion (primary or metastatic) present 1.5 cm or larger in any dimension on cross-sectional imaging (CT or MRI) obtained within 3 months of study enrollment. Results of CXCR4 immunohistochemistry or slides from biopsy of primary tumor or metastatic lesions available for study analysis. Participation in the Iowa Neuroendocrine Tumor Registry. Exclusion Criteria: Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Physical limitation that would limit compliance with the study requirements Pregnant or lactating women. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A negative pregnancy test will be required for all female subjects with child bearing potential. Planned administration of any NET therapy between scan 1 and 2, except for Somatostatin analog.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Veronica Howsare, AA, MA

Phone

(319) 384-6469

veronica-howsare@uiowa.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kristin Gaimari-Varner, RN, BSN

Phone

(319) 384-5489

kristin-gaimari-varner@uiowa.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yusuf Menda, MD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

M. Sue O'Dorisio, MD, PhD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

Holden Comprehensive Cancer Center

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Veronica Howsare, AA, MA

veronica-howsare@uiowa.edu

First Name & Middle Initial & Last Name & Degree

Kristin Gaimari-Varner, RN, BSN

Phone

(319) 384-5489

kristin-gaimari-varner@uiowa.edu

First Name & Middle Initial & Last Name & Degree

Yusuf Menda, MD

First Name & Middle Initial & Last Name & Degree

M. S. O'Dorisio, MD, PhD

First Name & Middle Initial & Last Name & Degree

Gideon Zamba, PhD

First Name & Middle Initial & Last Name & Degree

Andrew Bellizzi, MD

First Name & Middle Initial & Last Name & Degree

Daniel Berg, MD

First Name & Middle Initial & Last Name & Degree

David Bushnell, MD

First Name & Middle Initial & Last Name & Degree

Chandrikha Chandrasekharan, MD

First Name & Middle Initial & Last Name & Degree

David Dick, PhD

First Name & Middle Initial & Last Name & Degree

Joseph Dillon, MD

First Name & Middle Initial & Last Name & Degree

Lisa Dunnwald, MPH

First Name & Middle Initial & Last Name & Degree

Kristin Gaimari-Varner, RN, BSN

First Name & Middle Initial & Last Name & Degree

Silvia Ghobrial, MD

First Name & Middle Initial & Last Name & Degree

Michael M. Graham, MD, PhD

First Name & Middle Initial & Last Name & Degree

Veronica Howsare, AA, MA

First Name & Middle Initial & Last Name & Degree

Shannon Lehman, BA

First Name & Middle Initial & Last Name & Degree

Thomas O'Dorisio, MD

First Name & Middle Initial & Last Name & Degree

Janet Pollard, MD

First Name & Middle Initial & Last Name & Degree

Laura Ponto, PhD

First Name & Middle Initial & Last Name & Degree

Mary Schall, RN, BSN

First Name & Middle Initial & Last Name & Degree

John Sunderland, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data will be shared upon request to the study's principal investigator. A signed usage agreement will need to be provided.

IPD Sharing Time Frame

After the study has been completed.

IPD Sharing Access Criteria

Individual participant data will be shared upon request to the study's principal investigator. A signed usage agreement will need to be provided.

Citations:

PubMed Identifier

26909116

Citation

Lapa C, Luckerath K, Kleinlein I, Monoranu CM, Linsenmann T, Kessler AF, Rudelius M, Kropf S, Buck AK, Ernestus RI, Wester HJ, Lohr M, Herrmann K. (68)Ga-Pentixafor-PET/CT for Imaging of Chemokine Receptor 4 Expression in Glioblastoma. Theranostics. 2016 Jan 25;6(3):428-34. doi: 10.7150/thno.13986. eCollection 2016.

Results Reference

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PubMed Identifier

27819856

Citation

Bluemel C, Hahner S, Heinze B, Fassnacht M, Kroiss M, Bley TA, Wester HJ, Kropf S, Lapa C, Schirbel A, Buck AK, Herrmann K. Investigating the Chemokine Receptor 4 as Potential Theranostic Target in Adrenocortical Cancer Patients. Clin Nucl Med. 2017 Jan;42(1):e29-e34. doi: 10.1097/RLU.0000000000001435.

Results Reference

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PubMed Identifier

27175029

Citation

Herhaus P, Habringer S, Philipp-Abbrederis K, Vag T, Gerngross C, Schottelius M, Slotta-Huspenina J, Steiger K, Altmann T, Weisser T, Steidle S, Schick M, Jacobs L, Slawska J, Muller-Thomas C, Verbeek M, Subklewe M, Peschel C, Wester HJ, Schwaiger M, Gotze K, Keller U. Targeted positron emission tomography imaging of CXCR4 expression in patients with acute myeloid leukemia. Haematologica. 2016 Aug;101(8):932-40. doi: 10.3324/haematol.2016.142976. Epub 2016 May 12.

Results Reference

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Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors

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