Clinical trial NCT02055586: FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents
Official title: A Pilot Study of FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic solid tumors scheduled to undergo treatment with novel cancer therapeutic agents as SOC treatment at a cancer center hospital

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans
timeFrame: Baseline
measure: Comparative Analysis of PET/MRI Images
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Norbert Avril
role: PRINCIPAL_INVESTIGATOR
References: