Evaluating PARP-1 Expression in Pheochromocytoma and Paraganglioma Using PET/CT Imaging
Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Patients With Pheochromocytoma and Paraganglioma
This study is testing a new imaging method to see how a specific protein is expressed in tumors of patients with pheochromocytoma or paraganglioma before they receive treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05636540 on ClinicalTrials.gov |
What this trial studies
This study aims to enroll up to 30 patients diagnosed with pheochromocytoma or paraganglioma who are scheduled for surgical or systemic treatment. Participants will undergo a pre-treatment PET/CT scan using the investigational radiotracer 18F-FluorThanatrace to assess PARP-1 expression in their tumors. The study is observational, meaning that while imaging results will be available to patients and their physicians, treatment decisions will be based on standard clinical criteria rather than the PET/CT findings. Additionally, a subset of patients receiving systemic therapy may have a follow-up scan to evaluate changes in radiotracer uptake post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of pheochromocytoma or paraganglioma confirmed by imaging studies.
Not a fit: Patients who are unable to tolerate imaging procedures or are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of PARP-1 expression in pheochromocytoma and paraganglioma, potentially leading to improved treatment strategies.
How similar studies have performed: While this approach is novel in the context of pheochromocytoma and paraganglioma, similar imaging studies have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Heather Wachtel, MD — University of Pennsylvania
- Study coordinator: Heather Wachtel, MD
- Email: Heather.Wachtel@pennmedicine.upenn.edu
- Phone: 215-662-2341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.