Clinical trial NCT05636540: In Vivo PARP-1 Expression With 18F-FluorThanatrace PET/CT in Patients With Pheochromocytoma and Paraganglioma
Official title: Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Patients With Pheochromocytoma and Paraganglioma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Pheochromocytoma
Paraganglioma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot observational study to determine the feasibility of \[18F\]FTT PET/CT to evaluate PARP-1 enzyme expression in pheochromocytoma/paraganglioma.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Participants will be ≥ 18 years of age.
2. 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).
3. Standard of care germline genetic testing performed for clinical purposes or participant's consent for germline genetic testing for research purposes.
4. 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:

1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
2. 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.
3. 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 outcomes:
measure: Standard uptake value (SUV)measurement - [F18]FTT
timeFrame: Baseline
measure: Maximum standard uptake value (SUV)measurement - [F18]FTT
timeFrame: Baseline
measure: Mean Standard uptake value (SUV)measurement - [F18]FTT
timeFrame: Baseline
measure: Peak Standard uptake value (SUV)measurement - [F18]FTT
timeFrame: Baseline
measure: Standard uptake value (SUV)measurement - [F18]FTT
timeFrame: Follow-Up (1-21 days post therapy)
measure: Maximum standard uptake value (SUV)measurement - [F18]FTT
timeFrame: Follow-Up (1-21 days post therapy)
measure: Mean Standard uptake value (SUV)measurement - [F18]FTT
timeFrame: Follow-Up (1-21 days post therapy)
measure: Peak Standard uptake value (SUV)measurement - [F18]FTT
timeFrame: Follow-Up (1-21 days post therapy)
Secondary outcomes:
Other outcomes:
measure: Progression free survival (PFS)
timeFrame: From first day of treatment (PARP and/or ADT) to first documented disease progression or death due to any cause, assessed up to 10 years.
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Heather Wachtel, MD
role: PRINCIPAL_INVESTIGATOR
References: