[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

Trial Summary

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.

How is [18F]FluorThanatrace PET/CT imaging different from other treatments for pheochromocytoma and paraganglioma?

[18F]FluorThanatrace PET/CT imaging is unique because it uses a specific radioactive tracer to create detailed images of pheochromocytoma and paraganglioma, potentially offering more precise tumor localization and functional characterization compared to other imaging methods. This approach is part of a growing trend in PET imaging that moves beyond just locating tumors to understanding their behavior. ^{1 2 3 4 5}

What is the purpose of 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.

Research Team

Heather Wachtel, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Germany 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. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Clinical value of 18F-fluorodihydroxyphenylalanine positron emission tomography/computed tomography (18F-DOPA PET/CT) for detecting pheochromocytoma. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Pheochromocytomas: detection with 18F DOPA whole body PET--initial results.. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Current and future anatomical and functional imaging approaches to pheochromocytoma and paraganglioma. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Is there an optimal scan time for 6-[F-18]fluoro-L-DOPA PET in pheochromocytomas and paragangliomas? [2016]