[18F]FluorThanatrace PET/CT Imaging for Pheochromocytoma and Paraganglioma

Overseen By Julia T Lewandowski

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Heather Wachtel

Disqualifiers: Pregnancy, Breastfeeding, Imaging intolerance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on using a special scan, called [18F]FluorThanatrace ([18F]FTT) PET/CT, to examine tumors known as pheochromocytomas and paragangliomas. Researchers aim to observe how these tumors express a protein called PARP-1 before patients undergo surgery or other treatments. The trial will not alter the treatment of the condition; it is solely for observation and information gathering. Suitable participants have these tumors and have already identified them on a standard scan. As an Early Phase 1 trial, this study aims to understand how this new scanning method works in people, offering participants a chance to contribute to pioneering research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this PET/CT imaging technique is safe?

Research has shown that [18F]FluorThanatrace ([18F]FTT) is under study as a special imaging drug. It helps doctors assess the activity of a protein called PARP-1 in tumors. So far, studies have primarily evaluated its effectiveness in displaying these details in the body.

Detailed safety information for humans is not yet available, as this trial is in an early phase. This phase marks one of the first times [18F]FTT is tested in people. Early trials often focus on safety, with close monitoring of any side effects or reactions. Before reaching this phase, tests in animals and early human studies are typically conducted to ensure basic safety.

Prospective participants should know that any new treatment in early testing undergoes careful monitoring to ensure participant safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18F]FluorThanatrace (FTT) PET/CT imaging for pheochromocytoma and paraganglioma because it offers a potentially more precise way to visualize these tumors. Unlike traditional imaging methods, [18F]FTT targets a specific cellular component, which could help in distinguishing tumor tissue from normal tissue more effectively. This precision could lead to better treatment planning, as doctors would have clearer information about the tumor's location and extent. Additionally, by evaluating how tumors uptake [18F]FTT before and after systemic therapy, researchers hope to gain insights into the effectiveness of the treatment at an early stage, potentially leading to quicker adjustments in patient care.

What evidence suggests that this PET/CT imaging technique is effective for evaluating pheochromocytoma and paraganglioma?

Research shows that the experimental imaging agent [18F]FluorThanatrace (FTT) can help create clear pictures of certain tumors called pheochromocytoma and paraganglioma using a PET/CT scan. This scan allows doctors to see the activity of a protein called PARP-1, which is often found in large amounts in these tumors. Early studies in other cancers, such as breast cancer, have shown that [18F]FTT can effectively highlight areas with active PARP-1. This trial will evaluate [18F]FTT PET/CT in two separate cohorts: Cohort A, where participants will undergo a baseline scan before surgery, and Cohort B, where participants will have a baseline scan before systemic therapy, with an optional second scan after therapy initiation. More research is needed to confirm its effectiveness specifically for pheochromocytoma and paraganglioma. ^{2 6 7 8 9}

Who Is on the Research Team?

Heather Wachtel, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 with pheochromocytoma or paraganglioma, confirmed by tests and imaging like CT, MRI, or PET/CT. They must understand the study's research nature and agree to participate. Pregnant or breastfeeding women can't join, nor can those who can't handle imaging procedures or have conditions that may risk their safety in the trial.

Inclusion Criteria

I have been diagnosed with pheochromocytoma or paraganglioma, confirmed by tests and scans.

I have had genetic testing as part of my standard care or agreed to it for research.

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

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.

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.

Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline PET/CT Scan

Participants undergo a baseline experimental [18F]FTT PET/CT scan prior to surgery or systemic therapy

1 day

1 visit (in-person)

Surgery or Systemic Therapy

Participants undergo surgery or systemic therapy following the baseline PET/CT scan

Varies based on treatment

Optional Second PET/CT Scan

Up to 10 patients undergoing systemic therapy may undergo a second optional PET/CT scan to evaluate changes in [18F]FTT uptake

1-21 days after therapy initiation

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-21 days post therapy

What Are the Treatments Tested in This Trial?

Interventions

• [18F]FluorThanatrace ([18F]FTT)

Trial Overview [18F]FluorThanatrace ([18F]FTT) PET/CT scans are being tested to see how well they show PARP-1 expression in tumors of patients with pheochromocytoma or paraganglioma before surgery or systemic therapy. This observational study won't influence treatment decisions directly.

How Is the Trial Designed?

Group I: Cohort B Experimental Treatment 1 Intervention

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.

Group II: Cohort A Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Heather Wachtel

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study involving 14 patients suspected of having pheochromocytomas, (18)F DOPA PET demonstrated a 100% sensitivity in detecting tumors, outperforming MIBG scintigraphy, which had a sensitivity of only 71%.

Both (18)F DOPA PET and MR imaging showed 100% specificity, indicating that (18)F DOPA PET is a highly reliable imaging method for identifying pheochromocytomas and may be a promising option for future clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pheochromocytomas: detection with 18F DOPA whole body PET--initial results.. Hoegerle, S., Nitzsche, E., Altehoefer, C., et al.[2022]

F-18 DOPA PET imaging shows rapid uptake in pheochromocytomas and paragangliomas, with maximum tumor uptake reached as early as 20 minutes post-injection, making this the optimal time for static imaging.

The study found significant differences in standard uptake values (SUVs) between tumors and surrounding tissues, allowing for effective differentiation and localization of tumors during imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there an optimal scan time for 6-[F-18]fluoro-L-DOPA PET in pheochromocytomas and paragangliomas? Hentschel, M., Rottenburger, C., Boedeker, CC., et al.[2016]

There is no single 'gold-standard' imaging technique for detecting pheochromocytomas and paragangliomas (PPGLs), indicating the need for a personalized approach based on individual patient characteristics.

Recent advancements in PET imaging have shifted the focus from merely localizing tumors to also understanding their functional characteristics, enhancing the overall assessment of PPGLs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future anatomical and functional imaging approaches to pheochromocytoma and paraganglioma. Timmers, HJ., Taieb, D., Pacak, K.[2021]

In a study of 17 patients with metastatic pheochromocytoma or paraganglioma, (68)Ga-DOTATATE PET/CT demonstrated the highest sensitivity (93.3%) and accuracy (94.1%) for detecting these tumors compared to (131)I-MIBG scintigraphy and (18)F-FDG PET/CT.

(131)I-MIBG scintigraphy showed significantly lower sensitivity (46.7%) and accuracy (52.9%), while (18)F-FDG PET/CT had moderate sensitivity (90.9%) and accuracy (91.7%), indicating that (68)Ga-DOTATATE is the most effective imaging modality for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of (68)Ga-DOTATATE PET/CT, (18)F-FDG PET/CT and (131)I-MIBG Scintigraphy in Mapping Metastatic Pheochromocytoma and Paraganglioma. Tan, TH., Hussein, Z., Saad, FF., et al.[2022]

The combination of (18)F-DOPA PET/CT provides a 100% sensitivity and 88% specificity in accurately diagnosing and localizing pheochromocytoma (PHEO) lesions, outperforming either modality alone.

While (18)F-DOPA PET can identify PHEO lesions, it struggles with localization, whereas CT can localize lesions but often fails to confirm their presence; the combined approach resolves these limitations effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical value of 18F-fluorodihydroxyphenylalanine positron emission tomography/computed tomography (18F-DOPA PET/CT) for detecting pheochromocytoma. Luster, M., Karges, W., Zeich, K., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05636540

In Vivo PARP-1 Expression With 18F-FluorThanatrace PET ... This study will enroll up to 30 evaluable patients with pheochromocytoma or paraganglioma who are undergoing surgical or systemic treatment.

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/372915

In Vivo PARP-1 Expression With 18F-FluorThanatrace PET ... This study will enroll up to 30 evaluable patients with pheochromocytoma or paraganglioma who are undergoing surgical or systemic treatment.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-05514

18F-FluorThanatrace PET/CT for Detection of PARP-1 in ... This phase I trial evaluates a radioactive tracer, a type of imaging drug that is injected into the body to help see PARP-1 activity using an imaging ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11937411/

[18F]FluorThanatrace PET imaging as a biomarker of ... Here, we evaluate a radiolabeled PARPi, [ 18 F]FluorThanatrace ([ 18 F]FTT), as a functional biomarker of PARPi response in breast cancer.

5. withpower.com withpower.com/trial/early-phase-1-paraganglioma-1-2023-ad68b

[18F]FluorThanatrace PET/CT Imaging for ... [18F]FluorThanatrace PET/CT imaging is unique because it uses a specific radioactive tracer to create detailed images of pheochromocytoma and paraganglioma, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05636540

In Vivo PARP-1 Expression With 18F-FluorThanatrace PET ... Data will be collected to evaluate uptake of [18F]FTT in pheochromocytoma and paraganglioma and compare with PARP-1 activity and other experimental assays ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12012890/

[18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP- ... We first explore [18F]FTT in pre-clinical models of ovarian cancer using patient derived xenografts (PDX), followed by pilot data from a phase 2 clinical trial ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36441795/

[18F]FluorThanatrace ([18F]FTT) PET Imaging of ... - PubMed [18F]FluorThanatrace ([18F]FTT) is a PARPi-analog PET radiotracer that noninvasively measures PARP-1 expression. Herein, we evaluate [18F] ...

9. malacards.org malacards.org/card/hereditary_paraganglioma_pheochromocytoma_syndromes

Hereditary Paraganglioma-Pheochromocytoma Syndromes Hereditary paraganglioma-pheochromocytoma syndromes are rare, hereditary tumors arising from neuroendocrine chromaffin cells in the adrenal medulla or ...