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Trial Title:
In Vivo PARP-1 Expression With 18F-FluorThanatrace PET/CT in Patients With Pheochromocytoma and Paraganglioma
NCT ID:
NCT05636540
Condition:
Pheochromocytoma
Paraganglioma
Conditions: Official terms:
Pheochromocytoma
Paraganglioma
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a pilot observational study to determine the feasibility of [18F]FTT PET/CT to
evaluate PARP-1 enzyme expression in pheochromocytoma/paraganglioma.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[18F]FluorThanatrace ([18F]FTT)
Description:
A pre-treatment 18F-FluorThanatrace ([18F]FTT) positron emission tomography/computed
tomography (PET/CT) scan will be done prior to surgery or systemic therapy.
Arm group label:
Cohort A
Arm group label:
Cohort B
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.
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Abramson Cancer Center of the University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Start date:
July 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Heather Wachtel
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05636540
