FLT-PET/MRI for Early Response Monitoring to Novel Cancer... | NCT02055586

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

NCT02055586

Sponsor

Case Comprehensive Cancer Center

Status

Completed

Last Update Posted

Sep 18, 2020Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

fluorine F 18 fluorothymidine
positron emission tomography
magnetic resonance imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2013-01177	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2013Actual

Primary Completion Date

Nov 27, 2017Actual

Completion Date

Dec 27, 2017Actual

First Submitted Date

Feb 3, 2014

First Submission Date that Met QC Criteria

Feb 4, 2014

First Posted Date

Feb 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2020

Last Update Posted Date

Sep 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic (FLT-PET/MRI)		Patients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of treatment.	Other: fluorine F 18 fluorothymidine Device: positron emission tomography Device: magnetic resonance imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fluorine F 18 fluorothymidine	Other	Undergo FLT-PET/MRI	Diagnostic (FLT-PET/MRI)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with metastatic solid tumors scheduled to undergo treatment with novel cancer therapeutic agents as SOC treatment at a cancer center hospital

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Norbert Avril	Case Comprehensive Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Case Comprehensive Cancer Center		Cleveland	Ohio	44106-5065	United States

Intervention Browse Module

MeSH Terms

ID	Term
C002854	alovudine
D049268	Positron-Emission Tomography
D014055	Tomography, Emission-Computed
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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