[^18F] FLuorthanatrace PET/CT for Ovarian Cancer

Overseen By Lilie Lin

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

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: 3

300 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 trial team or your doctor.

Is [18F]Fluorthanatrace safe for use in humans?

The development of [18F]Fluorthanatrace included first-in-human imaging studies, which are initial tests in people to assess safety. While specific safety data is not detailed, these studies are a standard step in ensuring a treatment is safe for further testing. ^{1 2 3 4 5}

How is [18F] Fluorthanatrace PET/CT different from other treatments for ovarian cancer?

[18F] Fluorthanatrace PET/CT is unique because it uses a special imaging agent to measure the levels of a protein called PARP-1 in ovarian cancer, helping to predict how well a patient might respond to PARP inhibitors, which are a type of cancer drug. This approach is different from standard imaging techniques, as it provides specific information about the cancer's biology and potential treatment response. ^{1 4 5 6 7}

What is the purpose of this trial?

This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in patients with solid tumors. Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body. PET/CT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in patients with ovarian, fallopian tube, or primary peritoneal cancer.

Research Team

Lilie L. Lin

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with solid tumors, such as ovarian, fallopian tube, or primary peritoneal cancer. Participants must have at least one tumor lesion of 1.0 cm visible on standard imaging. Pregnant or breastfeeding women and those unable to tolerate imaging procedures are excluded.

Inclusion Criteria

I have or might have had a solid tumor in the past.

You have at least one abnormal spot that can be seen on a regular scan like CT or MRI and is at least 1.0 cm in size.

Exclusion Criteria

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

I am not pregnant or breastfeeding.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive FDG IV and undergo FDG PET/CT scan, followed by fluorine F 18 fluorthanatrace IV and [18F]FTT PET/CT

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

24 hours

1 visit (in-person)

Treatment Details

Interventions

• Fluorine F 18 Fluorthanatrace

Trial Overview The study tests how well a radioactive tracer called Fluorine F 18 fluorthanatrace works in PET/CT scans for detecting tumor cells in various cancers. It's a phase I trial focused on the effectiveness of this novel radiotracer in detailed body imaging.

Participant Groups

Group I: Treatment (FDG PET/CT, [18F]FTT PET/CT) Experimental Treatment 4 Interventions

Patients receive FDG IV and undergo FDG PET/CT scan over 20-30 minutes if they have not already had one per standard of care. At least 20-24 hours later, patients receive fluorine F 18 fluorthanatrace IV and undergo \[18F\]FTT PET/CT over 1 hour.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The study evaluated [18F]FluorThanatrace ([18F]FTT) as a biomarker to predict response to PARP inhibitors in homologous recombination deficient high-grade serous ovarian cancer, showing that a decrease in [18F]FTT uptake after treatment correlated with positive responses in patient-derived xenograft models and in 11 subjects.

In patients, a significant reduction in [18F]FTT uptake after about a week of PARP inhibitor treatment was associated with improved tumor response and progression-free survival, indicating that [18F]FTT could be a valuable tool for guiding PARP inhibitor therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP-Inhibitor Drug-Target Engagement as a Biomarker of Response in Ovarian Cancer, a Pilot Study. Pantel, AR., Gitto, SB., Makvandi, M., et al.[2023]

In a study of 152 ovarian cancer patients, (18)F-FDG PET/CT demonstrated high diagnostic performance with a sensitivity of 98.3% and specificity of 91.2%, making it a reliable tool for detecting recurrent tumors after therapy.

PET/CT was particularly effective in guiding clinical management decisions, such as diagnosing suspected recurrences and assessing treatment responses, highlighting its importance in the follow-up care of ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there an impact of 18F-FDG PET/CT on the surveillance and clinical management of recurrent ovarian cancer? Research based on a large sample in a single PET/CT center. Chen, YM., Chen, T., Zee, CS., et al.[2016]

This pilot study involving 14 patients demonstrated that PSMA 18F-DCFPyl PET/MR imaging can effectively detect ovarian cancer, showing significantly higher tracer uptake in malignant lesions compared to normal and benign ovarian tissues.

The results indicate that PSMA uptake is minimal in benign lesions, suggesting that this imaging technique could help differentiate between malignant and non-malignant ovarian conditions, warranting further research with larger patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distribution of prostate specific membrane antigen (PSMA) on PET-MRI in patients with and without ovarian cancer. Sadowski, EA., Lees, B., McMillian, AB., et al.[2023]

The development of the PET radiotracer 18F-FTT for imaging PARP-1 has progressed from preclinical evaluation to first-in-human studies, showing promise as a biomarker for measuring PARP-1 levels in breast and ovarian cancer patients.

The article outlines the regulatory process for submitting an investigational new drug application to the FDA and emphasizes the need for a commercialization strategy to facilitate multicenter clinical trials for future approval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of 18F Fluorthanatrace: A PET Radiotracer for Imaging Poly (ADP-Ribose) Polymerase-1. Lee, HS., Schwarz, SW., Schubert, EK., et al.[2023]

In a study of 21 women with ovarian cancer, integrated PET/CT imaging significantly improved the localization of cancer lesions, identifying 98% of lesions with definite localization compared to only 44% with PET alone.

PET/CT also reduced the number of equivocal lesions from 51% to 11%, enhancing the accuracy of characterizing lesions as benign or malignant, which is crucial for effective staging and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FDG PET and PET/CT in the Localization and Characterization of Lesions in Patients with Ovarian Cancer. Caprio, MG., Capacchione, D., Mainolfi, C., et al.[2021]

18F-FDG PET CT is increasingly used in clinical settings to assess ovarian, cervical, and endometrial cancers, providing significant benefits in staging, treatment selection, and early detection of recurrence.

Despite its growing use, the application of 18F-FDG PET CT does not always align with existing guidelines and expert recommendations, highlighting a need for better integration of this imaging technique in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of 18F-FDG PET CT in common gynaecological malignancies. Narayanan, P., Sahdev, A.[2018]

The study found that 18F-Fluciclovine PET/CT imaging achieved 100% sensitivity in detecting known ovarian cancer lesions in seven patients, indicating its effectiveness for accurate staging of the disease.

The uptake of 18F-Fluciclovine in ovarian lesions was significantly higher than background levels, suggesting it is a promising imaging agent for ovarian cancer, especially when imaged early at 4 minutes post-injection to minimize tracer washout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Experience with the Radiotracer 18F-Fluciclovine PET/CT in Ovarian Cancer. Buehner, TM., Liotta, M., Potkul, RK., et al.[2023]

References

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

[18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP-Inhibitor Drug-Target Engagement as a Biomarker of Response in Ovarian Cancer, a Pilot Study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Is there an impact of 18F-FDG PET/CT on the surveillance and clinical management of recurrent ovarian cancer? Research based on a large sample in a single PET/CT center. [2016]

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

Distribution of prostate specific membrane antigen (PSMA) on PET-MRI in patients with and without ovarian cancer. [2023]

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

The Development of 18F Fluorthanatrace: A PET Radiotracer for Imaging Poly (ADP-Ribose) Polymerase-1. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

18F-FDG PET and PET/CT in the Localization and Characterization of Lesions in Patients with Ovarian Cancer. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The role of 18F-FDG PET CT in common gynaecological malignancies. [2018]

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

Initial Experience with the Radiotracer 18F-Fluciclovine PET/CT in Ovarian Cancer. [2023]