FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents
NCT ID: NCT02055586
Last Updated: 2020-09-18
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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COMPLETED
10 participants
OBSERVATIONAL
2013-10-22
2017-12-27
Brief Summary
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Detailed Description
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The primary objective of this pilot imaging study is to determine the feasibility of FLTPET/MR imaging for early prediction of treatment response in patients undergoing antiangiogenic cancer treatment. The study will assess PET/MRI test-retest reproducibility and compare baseline PET/MRI with PET/MRI after initiation (within 2-4 weeks) of antiangiogenic therapy.
SECONDARY OBJECTIVES:
* To compare early changes in PET biomarker (FLT) tumor uptake with treatment response assessed at completion of therapy (prediction of treatment response).
* To compare changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy.
* To compare results from multi-parametric MR imaging with FLT tumor uptake.
* To assess combinations of quantitative PET and MRI metrics.
OUTLINE:
Patients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of treatment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Diagnostic (FLT-PET/MRI)
Patients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of treatment.
fluorine F 18 fluorothymidine
Undergo FLT-PET/MRI
positron emission tomography
Undergo FLT-PET/MRI
magnetic resonance imaging
Undergo FLT-PET/MRI
Interventions
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fluorine F 18 fluorothymidine
Undergo FLT-PET/MRI
positron emission tomography
Undergo FLT-PET/MRI
magnetic resonance imaging
Undergo FLT-PET/MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients able to tolerate PET/MRI scans
* Informed consent must be given and signed
* Subjects who refuse to give and/or sign the informed consent
* Patients who currently have a pacemaker
* Patients who have a history of serious adverse events related to a previous MRI or PET/CT
* Patients who are unable to undergo MRI scanning due to exclusion by UHCMC MRI restriction policies as mentioned in the standard UHCMC MRI informed consent form
* Patients with a known allergy against any component of the contrast enhancing agent
* Patients who currently pregnant or breast feeding; negative serum pregnancy test within 72 hours of their first FLT-PET/MRI
* Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 4 weeks
* Renal insufficiency: elevated creatinine and/or glomerular filtration rate (GFR) \< 40 ml/min/1.73\^2 (exclusion criterion only for contrast enhanced MRI)
18 Years
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Norbert Avril
Role: PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center
Locations
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Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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NCI-2013-01177
Identifier Type: REGISTRY
Identifier Source: secondary_id
CASE3Y12
Identifier Type: -
Identifier Source: org_study_id
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