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[18F]FluorThanatrace PET/CT Imaging for Pheochromocytoma and Paraganglioma

Phase < 1

Recruiting

Led By Heather Wachtel, MD

Research Sponsored by Heather Wachtel

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of pheochromocytoma or paraganglioma based on biochemical and imaging studies with at least one lesion identified on standard of care imaging (e.g. CT, MRI, FDG or 68-Gallium dotatate, other PET/CT or MIBG).

Participants will be ≥ 18 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow-up (1-21 days post therapy)

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate a PET/CT imaging scan to assess PARP-1 expression in pheochromocytoma/paraganglioma patients before surgery/systemic therapy. It won't influence treatment decisions.

Who is the study for?

This trial is for adults over 18 with pheochromocytoma or paraganglioma, confirmed by tests and imaging like CT, MRI, or PET/CT. They must understand the study's research nature and agree to participate. Pregnant or breastfeeding women can't join, nor can those who can't handle imaging procedures or have conditions that may risk their safety in the trial.

What is being tested?

[18F]FluorThanatrace ([18F]FTT) PET/CT scans are being tested to see how well they show PARP-1 expression in tumors of patients with pheochromocytoma or paraganglioma before surgery or systemic therapy. This observational study won't influence treatment decisions directly.

What are the potential side effects?

Since this is an observational study focusing on imaging techniques rather than drug effects, specific side effects related to [18F]FTT are not detailed here but may include typical risks associated with PET/CT scans such as exposure to radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with pheochromocytoma or paraganglioma, confirmed by tests and scans.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow-up (1-21 days post therapy)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow-up (1-21 days post therapy)

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up (1-21 days post therapy) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum standard uptake value (SUV)measurement - [F18]FTT

Mean Standard uptake value (SUV)measurement - [F18]FTT

Peak Standard uptake value (SUV)measurement - [F18]FTT

+1 more

Other study objectives

Progression free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment1 Intervention

After undergoing screening assessments and verifying eligibility for study participation subjects will be scheduled to undergo a baseline experimental \[18F\]FTT PET/CT scan prior to systemic therapy with radionuclide or chemotherapy. Up to 10 patients undergoing systemic therapy may undergo a second (optional) scan that will be performed approximately 1-21 days after therapy has started. The second scan is obtained to evaluate whether the initiation of systemic therapy alters \[18F\]FTT uptake. As this is a pilot study, only a limited number of patients are sought for the second scan.

Group II: Cohort AExperimental Treatment1 Intervention

0 / 2Eligibility criteria met