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

NCT05636540 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: UPCC 10322851463
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pheochromocytoma; Paraganglioma

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Progression free survival (PFS)

  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.

Study Arms (2)

Cohort A

EXPERIMENTAL

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)

Cohort B

EXPERIMENTAL

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)

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.

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heather Wachtel: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Pheochromocytoma; Paraganglioma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Heather Wachtel, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Wachtel, MD

CONTACT

215-662-2341; Heather.Wachtel@pennmedicine.upenn.edu

Julia T Lewandowski

CONTACT

215-662-2961; julia.lewandowski@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: This is a pilot observational study to determine the feasibility of \[18F\]FTT PET/CT to evaluate PARP-1 enzyme expression in pheochromocytoma/paraganglioma.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: December 5, 2022
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)