Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF
Breast CancerOvarian Cancer
Phase 1
M D Anderson Cancer Center
United States of America
Sponsor: M.D. Anderson Cancer Center
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.
Show Detailed Description
Radiation
Positron
Molecule
F-18 Fludeoxyglucose, F-18 d-FMAU
Target
DNA synthesis, Glucose metabolism
Trial Started
2018-12-18
Last Updated by Sponsor
2025-10-14
Estimated Completion
2027-06-30
Eligibility
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.
Design Details
AllocationN/A
Intervention ModelSingle Group Assignment
MaskingNone (Open Label)
Number to Enroll300
Arms & Interventions
Arms
Interventions
Type: Experimental
Description: 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.
Interventions:
Computed Tomography
Computed Tomography
Fludeoxyglucose F-18
Fluorine F 18 Fluorthanatrace
Positron Emission Tomography
Positron Emission Tomography
Outcome Measures
Primary Outcome Measures
Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomographyUp to 4 years
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.
Secondary Outcome Measures
Incidence of adverse eventsUp to 4 years
BRCA mutation statusUp to 4 years
To determine any correlation with BRCA status, fluorine F 18 fluorthanatrace ([18F]FTT) uptake values (mean and SD) across patient and lesion (summing across lesions) will be summarized, by BRCA status group. Group difference will be tested using t-tests.
PARP-1 activity in tumor tissue samplesUp to 4 years
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 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.
Change in fluorine F 18 fluorthanatrace uptake measures after therapyBaseline up to 4 years