FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Other: fluorine F 18 fluorothymidine
* Device: positron emission tomography
* Device: magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic (FLT-PET/MRI)<br>Patients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of treatment. | Other: fluorine F 18 fluorothymidine<br>* Undergo FLT-PET/MRI<br>* Other names: fluorothymidine F-18;Device: positron emission tomography<br>* Undergo FLT-PET/MRI<br>* Other names: tomography, emission computed;Device: magnetic resonance imaging<br>* Undergo FLT-PET/MRI<br>* Other names: nuclear magnetic resonance imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans | 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. | Baseline | 
| Comparative Analysis of PET/MRI Images | Describe changes in images at baseline PET/MRI scan compared to PET/MRI image taken after initiation of anti-angiogenic therapy | Up to 4 weeks |