NCT01807117

Brief Summary

This pilot clinical trial studies positron emission tomography (PET)-magnetic resonance imaging (MRI) and PET-computed tomography (CT) as diagnostic imaging in patients with colon and/or rectal cancer. New diagnostic imaging procedures, such as PET-MRI, may help find and diagnose rectal cancer or recurrence of colorectal cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

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

First Submitted

Initial submission to the registry

March 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2014

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

May 18, 2021

Completed
Last Updated

May 18, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

March 6, 2013

Results QC Date

February 23, 2021

Last Update Submit

April 26, 2021

Conditions

Recurrent Colon CancerRecurrent Rectal CancerStage IIA Colon CancerStage IIA Rectal CancerStage IIB Colon CancerStage IIB Rectal CancerStage IIC Colon CancerStage IIC Rectal CancerStage IIIA Colon CancerStage IIIA Rectal CancerStage IIIB Colon CancerStage IIIB Rectal CancerStage IIIC Colon CancerStage IIIC Rectal CancerStage IVA Colon CancerStage IVA Rectal CancerStage IVB Colon CancerStage IVB Rectal Cancer

Outcome Measures

Primary Outcomes (12)

  • Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and Fluorodeoxyglucose (FDG) Avid Lesions in Participants Where PET-CT Was Performed Prior to the PET-MRI

    SUV max in physiologic regions (blood pool, liver) and FDG avid lesions, in which the PET-CT was performed prior to the PET-MRI. SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

    Up to 6 months (each scan taking an average of 45 minutes)

  • Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and FDG Avid Lesions in Participants Where PET-MRI Was Performed Prior to the PET-CT

    SUV max in physiologic regions (blood pool, liver) and FDG avid lesions, in which the PET-MRI was performed prior to the PET-CT. SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

    Up to 6 months (each scan taking an average of 45 minutes)

  • SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI.

    SUVmax in FDG avid lesions in which the PET/CT was performed prior to the PET-MRI. SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

    Up to 6 months (each scan taking an average of 45 minutes)

  • SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT

    SUVmax in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

    Up to 6 months (each scan taking an average of 45 minutes)

  • SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI

    SUVmax ratio in FDG avid lesions in which the PET-CT was performed prior to the PET-MRI SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

    Up to 6 months (each scan taking an average of 45 minutes)

  • SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT

    SUVmax ratio in FDG avid lesions in which the PET-MRI was performed prior to the PET-CT SUVmax is defined as \[tissue concentration (MBq/g) x body weight (g)\]/\[injected dose (MBq/g)\]

    Up to 6 months (each scan taking an average of 45 minutes)

  • True Positive Rate

    True positive rate for both modalities - TP/TP+FN TP = true positives FN = False negatives

    Up to 6 months (each scan taking an average of 45 minutes)

  • True Negative Rate

    True negative rate for both modalities - TN/TN+FP TN = true negatives FP = False positives

    Up to 6 months (each scan taking an average of 45 minutes)

  • False Negative Rate

    False negative rate for both modalities - FN/FN+TP FN = False negatives TP = true positives

    Up to 6 months (each scan taking an average of 45 minutes)

  • Proportion of Lesions Identified by PET-CT That Were Correctly Detected by PET-MRI

    On a per-lesion basis, proportion of lesions identified by PET-CT that were correctly detected by PET-MRI

    Up to 6 months (each scan taking an average of 45 minutes)

  • Positive Predictive Values for PET-CT and PET-MRI

    Percent of true positive rate of diagnostic accuracy.

    Up to 6 months (each scan taking an average of 45 minutes)

  • Negative Predictive Values for PET-CT and PET-MRI

    Percent of true negative rate of diagnostic accuracy

    Up to 6 months (each scan taking an average of 45 minutes)

Study Arms (1)

Diagnostic (PET-CT and PET-MRI)

EXPERIMENTAL

Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.

Procedure: positron emission tomographyProcedure: computed tomographyProcedure: magnetic resonance imagingRadiation: fludeoxyglucose F 18

Interventions

positron emission tomographyPROCEDURE

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Diagnostic (PET-CT and PET-MRI)
computed tomographyPROCEDURE

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Also known as: tomography, computed
Diagnostic (PET-CT and PET-MRI)
magnetic resonance imagingPROCEDURE

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Diagnostic (PET-CT and PET-MRI)
fludeoxyglucose F 18RADIATION

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Also known as: 18FDG, FDG
Diagnostic (PET-CT and PET-MRI)

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Either having a T3 (the cancer has grown through the muscularis propria and into the outermost layers of the colon or rectum but not through them) or higher, node positivity or metastatic lesion in the context of rectal cancer or being studied for colorectal cancer follow up, independent of the renal function
  • PET-CT should be requested by a referring physician; in the case of having an MR requested as well, it will be reported from the MRI images generated in the PET-MRI
  • Stable physical medical conditions to undergo a MRI
  • Informed consent must be given and signed prior to study enrollment

You may not qualify if:

  • Refuse to give and/or sign the informed consent
  • Subjects who have a pacemaker
  • Subjects who have a metallic prostheses either in the pelvis or in the abdomen that will interfere with the MR imaging of that anatomical area
  • Subjects who suffer from claustrophobia
  • Pregnant women
  • Cognitive impairment that affects the subject's ability to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Interventions

Magnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazoleFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Results Point of Contact

Title
Dr. Raj Paspulati
Organization
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Raj.Paspulati@UHhospitals.org
1-800-641-2422

Study Officials

  • Raj Paspulati, MD

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 8, 2013

Study Start

April 1, 2013

Primary Completion

March 5, 2014

Study Completion

March 5, 2014

Last Updated

May 18, 2021

Results First Posted

May 18, 2021

Record last verified: 2021-04

Locations

US(1)