Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors

NCT03335670 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 201708705P50CA174521
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Within 1 month of [68Ga]Pentixafor scan

• 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.

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

Secondary Outcomes (2)

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

  Within 6 months of [68Ga]Pentixafor scan

• 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.

  Within 6 months of [68Ga]Pentixafor scan

Study Arms (1)

[68Ga]Pentixafor PET scan

EXPERIMENTAL

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.

Drug: [68Ga]Pentixafor

Interventions

[68Ga]Pentixafor DRUG

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

Also known as: (68Ga)pentixafor

[68Ga]Pentixafor PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yusuf Menda: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator
• Holden Comprehensive Cancer Center: collaborator

Study Sites (1)

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Related Publications (3)

• 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.

  PMID: 26909116 BACKGROUND

• 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.

  PMID: 27819856 BACKGROUND

• 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.

  PMID: 27175029 BACKGROUND

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

68Ga-pentixafor

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Yusuf Menda, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• M. Sue O'Dorisio, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 8, 2017
• Study Start: November 3, 2017
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the study has been completed.
• 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.

Locations

US (1)