PheochromocytomaEarly Phase 1NCT05636540
In Vivo PARP-1 Expression With 18F-FluorThanatrace PET/CT in Patients With Pheochromocytoma and Paraganglioma
A Early Phase 1 study testing [18F]FluorThanatrace ([18F]FTT) in people with Pheochromocytoma and Paraganglioma, run by Heather Wachtel at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pheochromocytoma, Paraganglioma
- What is being tested?
- [18F]FluorThanatrace ([18F]FTT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Patients With Pheochromocytoma and Paraganglioma
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.
Read the 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.
- Conditions
- Pheochromocytoma, Paraganglioma
- Being tested
- [18F]FluorThanatrace ([18F]FTT)
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [18F]FluorThanatrace ([18F]FTT) |
| 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. Receives: Drug: [18F]FluorThanatrace ([18F]FTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard uptake value (SUV)measurement - [F18]FTT
Qualitative measure SUV of [18F]FTT in phenochromocytoma/paraganlioma region (categories: positive, negative or mixed)
Measured: Baseline
Maximum standard uptake value (SUV)measurement - [F18]FTT
Measure of maximum SUV of [18F}FTT in primary lesion region
Measured: Baseline
Mean Standard uptake value (SUV)measurement - [F18]FTT
Measure of mean SUV of [18F}FTT in primary lesion region
Measured: Baseline
Peak Standard uptake value (SUV)measurement - [F18]FTT
Measure of peak SUV of [18F}FTT in primary lesion region
Measured: Baseline
Standard uptake value (SUV)measurement - [F18]FTT
Qualitative measure SUV of [18F]FTT in phenochromocytoma/paraganlioma region (categories: positive, negative or mixed)
Measured: 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
Measured: 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
Measured: Follow-Up (1-21 days post therapy)
Peak Standard uptake value (SUV)measurement - [F18]FTT
Measure of peak SUV of [18F}FTT in primary lesion region
Measured: Follow-Up (1-21 days post therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heather Wachtel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heather Wachtel, Abramson Cancer Center at Penn Medicine
- Investigators
- Heather Wachtel, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636540
- Sponsor's protocol ID
- UPCC 10322
- Other IDs
- 851463
- Status last verified
- Feb 2026
- First submitted
- 20 Oct 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Patients With Pheochromocytoma and Paraganglioma
- ClinicalTrials.gov ID
- NCT05636540
- Acronym / sponsor ID
- UPCC 10322
- Conditions
- Pheochromocytoma, Paraganglioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Heather WachtelUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: [18F]FluorThanatrace ([18F]FTT)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 | Drug: [18F]FluorThanatrace ([18F]FTT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [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. | Drug | Cohort A, Cohort B |
Primary outcome
Standard uptake value (SUV)measurement - [F18]FTT
Time frame: Baseline
Qualitative measure SUV of [18F]FTT in phenochromocytoma/paraganlioma region (categories: positive, negative or mixed)
Maximum standard uptake value (SUV)measurement - [F18]FTT
Time frame: Baseline
Measure of maximum SUV of [18F}FTT in primary lesion region
Mean Standard uptake value (SUV)measurement - [F18]FTT
Time frame: Baseline
Measure of mean SUV of [18F}FTT in primary lesion region
Peak Standard uptake value (SUV)measurement - [F18]FTT
Time frame: Baseline
Measure of peak SUV of [18F}FTT in primary lesion region
Standard uptake value (SUV)measurement - [F18]FTT
Time frame: Follow-Up (1-21 days post therapy)
Qualitative measure SUV of [18F]FTT in phenochromocytoma/paraganlioma region (categories: positive, negative or mixed)
Maximum standard uptake value (SUV)measurement - [F18]FTT
Time frame: Follow-Up (1-21 days post therapy)
Measure of maximum SUV of [18F}FTT in primary lesion region
Mean Standard uptake value (SUV)measurement - [F18]FTT
Time frame: Follow-Up (1-21 days post therapy)
Measure of mean SUV of [18F}FTT in primary lesion region
Peak Standard uptake value (SUV)measurement - [F18]FTT
Time frame: Follow-Up (1-21 days post therapy)
Measure of peak SUV of [18F}FTT in primary lesion region
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Wachtel, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]FluorThanatrace ([18F]FTT) in people with Pheochromocytoma and Paraganglioma, run by Heather Wachtel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Wachtel, MD (215-662-2341, Heather.Wachtel@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard uptake value (SUV)measurement - [F18]FTT (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.