Unspecified Adult Solid Tumor, Protocol Specific
Conditions
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.
Interventions
Undergo FLT-PET/MRI
DEVICEpositron emission tomography
Undergo FLT-PET/MRI
DEVICEmagnetic resonance imaging
Undergo FLT-PET/MRI
Sponsors
Case Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed