18F-FluorThanatrace PET/CT for Detection of PARP-1 in Patients with Pheochromocytoma and Paraganglioma

Status: active

This phase I trial evaluates a radioactive tracer, a type of imaging drug that is injected into the body to help see PARP-1 activity using an imaging procedure called positron emission tomography (PET)/computed tomography (CT) in patients with pheochromocytoma and paraganglioma (tumor that forms in the center of the adrenal gland [gland located above the kidney]). Poly (ADP-ribose) polymerase-1 is also called PARP-1, is a protein in the body that helps with many cell processes. PARP-1 has been studied for a number of years in cancer treatment as PARP inhibitor drugs. 18fluorine-fluorthanatrace ([18F]-FTT) is a specialized radioactive imaging drug used to create pictures or images of areas where doctors think tumor is from, pheochromocytoma or paraganglioma, that might have PARP-1 activity. This study may help researchers learn whether test 18F-FTT can show PARP-1 activity in patients with pheochromocytoma and paraganglioma.

Inclusion Criteria

Participants will be >= 18 years of age.
Clinical diagnosis of pheochromocytoma or paraganglioma based on biochemical and imaging studies. At least one lesion identified on standard of care imaging (e.g. CT, MRI, FDG or 68-Gallium dotatate, other PET/CT or MIBG).
Standard of care germline genetic testing performed for clinical purposes or participant’s consent for germline genetic testing for research purposes.
Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria

Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
Females who are pregnant or breastfeeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to FTT injection.
Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.

PRIMARY OBJECTIVE:

I. To evaluate PARP-1 activity in pheochromocytoma and paraganglioma using measures of uptake of [18F]fluorthanatrace.

SECONDARY OBJECTIVES:

I. To correlate [18F]fluorthanatrace uptake measures with PARP-1 activity in the biopsy and/or surgical specimen 1 [125I]KX1 autoradiography activity.

II. To correlate [18F]fluorthanatrace uptake measures with known hereditary predisposition genes.

OUTLINE:

Patients receive [18F]-FFT intravenously (IV) and undergo PET/CT over 60 minutes prior to start of PARP inhibitor therapy, chemotherapy and/or ADT. Patients may also receive additional [18F]-FFT IV and undergo PET/CT 1-21 days after start of PARP inhibitor therapy, chemotherapy and/or ADT. Patients may also undergo tumor tissue sample collection on study.

After completion of study treatment, patients are followed up 24 hours following [18F]-FTT injection.

Have a question?
We're here to help

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Which trials are right for you?

Use the checklist in our guide to gather the information you’ll need.

18F-FluorThanatrace PET/CT for Detection of PARP-1 in Patients with Pheochromocytoma and Paraganglioma

Inclusion Criteria

Exclusion Criteria

United States

Pennsylvania

Philadelphia

Have a question?
We're here to help

Which trials are right for you?

18F-FluorThanatrace PET/CT for Detection of PARP-1 in Patients with Pheochromocytoma and Paraganglioma

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help