Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 851463 | Other Identifier | University of Pennsylvania IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.](streamdown:incomplete-link)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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](streamdown:incomplete-link) | Baseline |
| Mean Standard uptake value (SUV)measurement - [F18]FTT | Measure of mean SUV of [18F}FTT in primary lesion region](streamdown:incomplete-link) | Baseline |
| Peak Standard uptake value (SUV)measurement - [F18]FTT | Measure of peak SUV of [18F}FTT in primary lesion region](streamdown:incomplete-link) | 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](streamdown:incomplete-link) | 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](streamdown:incomplete-link) | Follow-Up (1-21 days post therapy) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Time from initial participation in study to disease progression or death from any cause, | 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heather Wachtel, MD | Contact | 215-662-2341 | Heather.Wachtel@pennmedicine.upenn.edu | |
| Julia T Lewandowski | Contact | 215-662-2961 | julia.lewandowski@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heather Wachtel, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010673 | Pheochromocytoma |
| D010235 | Paraganglioma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
This is a pilot observational study to determine the feasibility of [18F]FTT PET/CT to evaluate PARP-1 enzyme expression in pheochromocytoma/paraganglioma.
Not provided
Not provided
Not provided
Not provided
| Peak Standard uptake value (SUV)measurement - [F18]FTT |
Measure of peak SUV of [18F}FTT in primary lesion region](streamdown:incomplete-link) |
| Follow-Up (1-21 days post therapy) |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |