Recruiting
Early Phase 1

PARP-1 Expression

Sponsor:

Heather Wachtel

Code:

NCT05636540

Conditions

Pheochromocytoma

Paraganglioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F]FluorThanatrace ([18F]FTT)

Study Details

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

Study ID

NCT05636540

Start date

Jul 1, 2023

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

Interventions

[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.

Primary outcome measure

  • Standard uptake value (SUV)measurement - [F18]FTT [ Time Frame: Baseline ]
  • Maximum standard uptake value (SUV)measurement - [F18]FTT [ Time Frame: Baseline ]
  • Mean Standard uptake value (SUV)measurement - [F18]FTT [ Time Frame: Baseline ]
  • Peak Standard uptake value (SUV)measurement - [F18]FTT [ Time Frame: Baseline ]
  • Standard uptake value (SUV)measurement - [F18]FTT [ Time Frame: Follow-Up (1-21 days post therapy) ]
  • Maximum standard uptake value (SUV)measurement - [F18]FTT [ Time Frame: Follow-Up (1-21 days post therapy) ]
  • Mean Standard uptake value (SUV)measurement - [F18]FTT [ Time Frame: Follow-Up (1-21 days post therapy) ]
  • Peak Standard uptake value (SUV)measurement - [F18]FTT [ Time Frame: Follow-Up (1-21 days post therapy) ]

Central Contacts and Locations

Locations

Abramson Cancer Center of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Heather Wachtel

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Heather Wachtel on 2026-02-27.