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Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.


N/A
22 Years
N/A
Not Enrolling
Both
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIA Colon Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer, Stage IIB Rectal Cancer, Stage IIC Colon Cancer, Stage IIC Rectal Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

Thank you

Trial Information

Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.


PRIMARY OBJECTIVES:

I. To test the diagnostic performance of PET- MRI in the staging of preoperative high-grade
rectal cancer patients, defined by T3 stage or higher or N1 stage or higher or presence of
metastasis, that are referred to PET-CT and MRI.

II. To test the diagnostic performance of PET-MRI the follow up of colorectal cancer
patients that are referred to PET-CT with or without a diagnostic MRI request by their
physicians.

SECONDARY OBJECTIVES:

I. To test different attenuation correction MR sequences and novel diagnostic MR sequences.

OUTLINE:

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


Inclusion Criteria:



- 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

Exclusion Criteria:

- Refuse to give and/or sign the informed consent

- Subjects who do not meet the above mentioned inclusion criteria

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity for PET-CT and PET-MRI

Outcome Description:

Calculated with its 95% confidence interval using the standard formulas according to the criterion standard. Continuous variables will be expressed as mean and standard deviation. Comparisons between continuous variables will be performed by using the Student t test. Comparisons between qualitative variables will be performed by using the chi-square test with the Yates' correction or McNemar's test as appropriate.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Raj Paspulati, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE8212

NCT ID:

NCT01807117

Start Date:

March 2013

Completion Date:

June 2014

Related Keywords:

  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IIA Colon Cancer
  • Stage IIA Rectal Cancer
  • Stage IIB Colon Cancer
  • Stage IIB Rectal Cancer
  • Stage IIC Colon Cancer
  • Stage IIC Rectal Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIA Rectal Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIIC Colon Cancer
  • Stage IIIC Rectal Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms

Name

Location
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065