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

ConditionsPheochromocytomaParaganglioma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeather Wachtel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • [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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Cohort AExperimental treatment 1 intervention
Group B: Cohort BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Standard uptake value (SUV)measurement - [F18]FTT

Qualitative measure SUV of \[18F\]FTT in phenochromocytoma/paraganlioma region (categories: positive, negative or mixed)

Time frame
Baseline
2

Maximum standard uptake value (SUV)measurement - [F18]FTT

Measure of maximum SUV of \[18F}FTT in primary lesion region

Time frame
Baseline
3

Mean Standard uptake value (SUV)measurement - [F18]FTT

Measure of mean SUV of \[18F}FTT in primary lesion region

Time frame
Baseline
4

Peak Standard uptake value (SUV)measurement - [F18]FTT

Measure of peak SUV of \[18F}FTT in primary lesion region

Time frame
Baseline

Secondary outcomes

Other outcomes

1

Progression free survival (PFS)

Time from initial participation in study to disease progression or death from any cause,

Time frame
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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heather Wachtel

Lead sponsor

Abramson Cancer Center at Penn Medicine

Sponsor institution

Source ClinicalTrials.gov
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