Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF
NCT ID: NCT03604315
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
300 participants
INTERVENTIONAL
2018-12-18
2027-06-30
Brief Summary
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Detailed Description
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\- 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (FDG PET/CT, [18F]FTT PET/CT)
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.
Computed Tomography
Undergo FDG PET/CT
Computed Tomography
Undergo \[18F\]FTT PET/CT
Fludeoxyglucose F-18
Given IV
Fluorine F 18 Fluorthanatrace
Given IV
Positron Emission Tomography
Undergo FDG PET/CT
Positron Emission Tomography
Undergo \[18F\]FTT PET/CT
Interventions
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Computed Tomography
Undergo FDG PET/CT
Computed Tomography
Undergo \[18F\]FTT PET/CT
Fludeoxyglucose F-18
Given IV
Fluorine F 18 Fluorthanatrace
Given IV
Positron Emission Tomography
Undergo FDG PET/CT
Positron Emission Tomography
Undergo \[18F\]FTT PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lilie L Lin
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2018-01137
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0319
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0319
Identifier Type: -
Identifier Source: org_study_id
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