Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yusuf Menda
• Collaborators: Holden Comprehensive Cancer Center; National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Alprazolam

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Histological diagnosis of neuroendocrine tumor (NET).

3. 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.

4. 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.

5. Results of CXCR4 immunohistochemistry or slides from biopsy of primary tumor or metastatic lesions available for study analysis.

6. Participation in the Iowa Neuroendocrine Tumor Registry.

Exclusion Criteria:

1. 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.

2. Physical limitation that would limit compliance with the study requirements

3. 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.

4. Planned administration of any NET therapy between scan 1 and 2, except for Somatostatin analog.