FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT02055586
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT)-positron emission tomography/magnetic resonance imaging (PET/MRI) in measuring early response in patients with metastatic solid tumors receiving treatment that blocks blood flow to the tumor. Diagnostic procedures, such as FLT-PET/MRI, may help measure a patient's response earlier during treatment.
- Detailed Description
PRIMARY OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- Patients with metastatic solid tumors scheduled to undergo treatment with novel cancer therapeutic agents as standard of care (SOC) treatment.
- Patients able to tolerate PET/MRI scans
- Informed consent must be given and signed
- Subjects who do not meet the above mentioned inclusion criteria
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans Baseline A sample size of 20 produces a two-sided 95% confidence interval \[0.553, 0.918\] for the Pearson correlation coefficient when the sample correlation is 0.80. Additional analysis for concordance will include Bland-Altman plots and intraclass correlation.
Comparative Analysis of PET/MRI Images Up to 4 weeks Describe changes in images at baseline PET/MRI scan compared to PET/MRI image taken after initiation of anti-angiogenic therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Case Comprehensive Cancer Center🇺🇸Cleveland, Ohio, United States