In Vivo PARP-1 Expression With 18F-FluorThanatrace PET/CT in Patients With Pheochromocytoma and Paraganglioma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Heather Wachtel
Study ID
NCT05636540
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Paraganglioma
  • Pheochromocytoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [18F]FluorThanatrace ([18F]FTT) — DRUG
    A pre-treatment 18F-FluorThanatrace (\[18F\]FTT) positron emission tomography/computed tomography (PET/CT) scan will be done prior to surgery or systemic therapy.

Study Details

This study will enroll up to 30 evaluable patients with pheochromocytoma or paraganglioma who are undergoing surgical or systemic treatment. A pre-treatment 18F-FluorThanatrace (\[18F\]FTT) positron emission tomography/computed tomography (PET/CT) scan will be done prior to surgery or systemic therapy. PET/CT imaging will be used to evaluate PARP-1 expression in sites of pheochromocytoma or paraganglioma using the investigational radiotracer \[18F\]FTT. This is an observational study in that \[18F\]FTT PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the \[18F\]FTT PET/CT results, treatment decisions will be made by the treating physicians based upon clinical criteria.

Key Dates

Start date
Jul 1, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort A
    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 surgery. Patients in Cohort A will undergo surgery with or without additional therapy.
  • Experimental: Cohort B
    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.

Primary Outcome Measure

Standard uptake value (SUV)measurement - [F18]FTT [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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