RecruitingRecruiting
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF
NCT03604315 · M.D. Anderson Cancer Center
In plain English
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Official title
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT
About this study
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.
Eligibility criteria
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 design
Enrollment target: 300 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-12-18
Estimated completion: 2027-06-30
Last updated: 2026-04-15
Interventions
Procedure: Computed TomographyProcedure: Computed TomographyRadiation: Fludeoxyglucose F-18Radiation: Fluorine F 18 FluorthanatraceProcedure: Positron Emission TomographyProcedure: Positron Emission Tomography
Primary outcomes
- • Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography (Up to 4 years)
Sponsor
M.D. Anderson Cancer Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactLilie Lin · contact · lllin@mdanderson.org · 713-563-2300
InvestigatorLilie L Lin · principal_investigator, M.D. Anderson Cancer Center
All locations (1)
M D Anderson Cancer CenterRecruiting
Houston, Texas, United States