RecruitingInterventionalPhase 1

Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT

NCT ID: NCT03604315Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-04-15

Summary

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.

Detailed description

PRIMARY OBJECTIVES: \- Evaluate fluorine F 18 fluorthanatrace (\[18F\]Fluorthanatrace) positron emission tomography/computed tomography (PET/CT) as an imaging biomarker of poly \[ADP-ribose\] polymerase (PARP)-1 activity in 3 cohorts of cancer patients: 1) ovarian, fallopian tube, primary peritoneal 2) breast cancer, and 3) non-ovarian, non-breast solid tumor. SECONDARY OBJECTIVES: * Evaluate the safety of \[18F\]Fluorthanatrace. * Correlate \[18F\]Fluorthanatrace uptake measures with BRCA mutation status. * Correlate \[18F\]Fluorthanatrace uptake measures with poly \[ADP-ribose\] polymerase (PARP-1) activity in tumor tissue samples in patients who undergo biopsies. * Evaluate change in \[18F\]Fluorthanatrace uptake measures after therapy initiation with repeat imaging before and after treatment initiation. * To confirm the variability of imaging findings from repeated \[18F\]FTT PET/CT over 1 week before treatment initiation * Determine the change in \[18F\]FluorThanatrace uptake before treatment initiation and at time of clinical progression * Correlate \[18F\]FluorThanatrace uptake at time of clinical progression measures with genetic reversion mutation status OUTLINE: Patients receive fluorodeoxyglucose (FDG) intravenously (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 fluorine F 18 fluorthanatrace (\[18F\]FTT) PET/CT over 1 hour. After completion of study treatment, patients are followed up at 24 hours.

Arms & interventions

ProcedureComputed Tomography
Undergo FDG PET/CT
ProcedureComputed Tomography
Undergo \[18F\]FTT PET/CT
RadiationFludeoxyglucose F-18
Given IV
RadiationFluorine F 18 Fluorthanatrace
Given IV
ProcedurePositron Emission Tomography
Undergo FDG PET/CT
ProcedurePositron Emission Tomography
Undergo \[18F\]FTT PET/CT

Outcome measures

Primary

Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography
Data will be generated for semi-parametric uptake of both tracers by patient and by lesion as well as by PARP activity, and summarized as mean and standard deviation (SD) across patients. For patients for whom tumor tissue is saved, the correlation of uptake values and PARP activity as assayed from biopsy specimens will be measured using the rank correlation (Spearman's rho), and test for significance compared to no correlation.
Time frame: Up to 4 years

Secondary

Incidence of adverse events
Time frame: Up to 4 years
BRCA mutation status
Time frame: Up to 4 years
PARP-1 activity in tumor tissue samples
Time frame: Up to 4 years
Change in fluorine F 18 fluorthanatrace uptake measures after therapy
Time frame: Baseline up to 4 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: * History of known or suspected solid tumor. * At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. computed tomography \[CT\], magnetic resonance imaging \[MRI\], ultrasound, fludeoxyglucose \[FDG\] PET/CT). Exclusion Criteria: * Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential \< 2 weeks prior to screening as standard of care. * Inability to tolerate imaging procedures in the opinion of an investigator or treating physician. * 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.

Study locations (1)

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Lilie L. Lin, MD · Contact

713-563-2300 lllin@mdanderson.org

Lilie L. Lin, MD · Principal Investigator

References

Lin LL, Wong F, Lin R, Yap T, Litton JK. Pharmacodynamic Activity of [18F]-Fluorthanatrace Poly(ADP-ribose) Polymerase Positron Emission Tomography in Patients With BRCA1/2-Mutated Breast Cancer Receiving Talazoparib. JCO Precis Oncol. 2024 Aug;8:e2400303. doi: 10.1200/PO.24.00303.(PubMed)