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

Recruiting in Palo Alto (17 mi)

Overseen by Lilie L. Lin

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Breastfeeding, Imaging intolerance, others

No Placebo Group

Trial Summary

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.

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}

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.

Trial 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 (Radiotracer)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3107

Patients Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

Findings from Research

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]