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

Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Patients With Pheochromocytoma and Paraganglioma

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.

Study Overview

• Status: Recruiting
• Conditions: Pheochromocytoma; Paraganglioma
• Intervention / Treatment: Drug: [18F]FluorThanatrace ([18F]FTT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Heather Wachtel, MD; Phone Number: 215-662-2341; Email: Heather.Wachtel@pennmedicine.upenn.edu
• Study Contact Backup: Name: Julia T Lewandowski; Phone Number: 215-662-2961; Email: julia.lewandowski@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: [18F]FluorThanatrace ([18F]FTT); A pre-treatment 18F-FluorThanatrace ([18F]FTT) positron emission tomography/computed tomography (PET/CT) scan will be done prior to surgery or systemic 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.	Drug: [18F]FluorThanatrace ([18F]FTT); A pre-treatment 18F-FluorThanatrace ([18F]FTT) positron emission tomography/computed tomography (PET/CT) scan will be done prior to surgery or systemic therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard uptake value (SUV)measurement - [F18]FTT	Qualitative measure SUV of [18F]FTT in phenochromocytoma/paraganlioma region (categories: positive, negative or mixed)	Baseline
Maximum standard uptake value (SUV)measurement - [F18]FTT	Measure of maximum SUV of [18F}FTT in primary lesion region	Baseline
Mean Standard uptake value (SUV)measurement - [F18]FTT	Measure of mean SUV of [18F}FTT in primary lesion region	Baseline
Peak Standard uptake value (SUV)measurement - [F18]FTT	Measure of peak SUV of [18F}FTT in primary lesion region	Baseline
Standard uptake value (SUV)measurement - [F18]FTT	Qualitative measure SUV of [18F]FTT in phenochromocytoma/paraganlioma region (categories: positive, negative or mixed)	Follow-Up (1-21 days post therapy)
Maximum standard uptake value (SUV)measurement - [F18]FTT	Measure of maximum SUV of [18F}FTT in primary lesion region	Follow-Up (1-21 days post therapy)
Mean Standard uptake value (SUV)measurement - [F18]FTT	Measure of mean SUV of [18F}FTT in primary lesion region	Follow-Up (1-21 days post therapy)
Peak Standard uptake value (SUV)measurement - [F18]FTT	Measure of peak SUV of [18F}FTT in primary lesion region	Follow-Up (1-21 days post therapy)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	Time from initial participation in study to disease progression or death from any cause,	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.

Collaborators and Investigators

• Sponsor: Heather Wachtel
• Investigators: Principal Investigator: Heather Wachtel, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Pheochromocytoma; Paraganglioma
• Other Study ID Numbers: UPCC 10322; 851463 (Other Identifier: University of Pennsylvania IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No