Status:
ACTIVE_NOT_RECRUITING
Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors
Lead Sponsor:
Yusuf Menda
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 i...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03335670
Start Date
November 3 2017
End Date
June 30 2030
Last Update
July 14 2025
Active Locations (1)
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1
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242