NCT02055586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2017

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

4.1 years

First QC Date

February 3, 2014

Last Update Submit

September 17, 2020

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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 fluorothymidineDevice: positron emission tomographyDevice: magnetic resonance imaging

Interventions

fluorine F 18 fluorothymidineOTHER

Undergo FLT-PET/MRI

Also known as: 18F-FLT, 3'-deoxy-3'-[18F]fluorothymidine, fluorothymidine F-18
Diagnostic (FLT-PET/MRI)
positron emission tomographyDEVICE

Undergo FLT-PET/MRI

Also known as: PET/MR, PET, PET scan, tomography, emission computed
Diagnostic (FLT-PET/MRI)
magnetic resonance imagingDEVICE

Undergo FLT-PET/MRI

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Diagnostic (FLT-PET/MRI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Interventions

alovudinePositron-Emission TomographyTomography, Emission-ComputedMagnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Norbert Avril

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 5, 2014

Study Start

October 22, 2013

Primary Completion

November 27, 2017

Study Completion

December 27, 2017

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

US(1)