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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Up to 30 patients who will undergo approximately 60 minutes of dynamic scanning head to thigh starting at approximately the same time as the injection, this will be followed by a second head to thigh scan [starting at approximately 90 minutes post injection. PET/CT imaging sessions will include an injection of ≤ 12 mCi of [18F]FTT intravenously (approximate range for most studies is anticipated to be 8-12 mCi). If surgery is performed according to standard of care tissue will be processed for both clinical and research use, if the subject has consented for use of tissue. Data will be collected to evaluate uptake of [18F]FTT in pheochromocytoma and paraganglioma and compare with PARP-1 activity and other experimental assays in tissue from biopsy and surgery, when available. All evaluable patients may undergo surgery or systemic therapy following the [18F]FTT PET/CT scan. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05636540
Study type	Interventional
Source	Abramson Cancer Center at Penn Medicine
Contact	Heather Wachtel, MD
Phone	215-662-2341
Email	Heather.Wachtel@pennmedicine.upenn.edu
Status	Recruiting
Phase	Early Phase 1
Start date	July 1, 2023
Completion date	December 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms