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Completed

NCT Number: NCT01807117

PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

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

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Key information

Conditions

Recurrent Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms 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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positron Emission Tomography

Procedure

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Other names: FDG-PET, PET, PET scan, tomography, emission computed

Computed Tomography

Procedure

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Other names: tomography, computed

Magnetic Resonance Imaging

Procedure

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Other names: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

fludeoxyglucose F 18

Radiation

Undergo fludeoxyglucose F 18 PET-CT and PET-MRI

Other names: 18FDG, FDG

Primary outcomes

  1. 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

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

    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)]

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

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

    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)]

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

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

    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)]

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

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

    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)]

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

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

    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)]

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

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

    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)]

  7. True Positive Rate

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

    True positive rate for both modalities - TP/TP+FN

    TP = true positives FN = False negatives

  8. True Negative Rate

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

    True negative rate for both modalities - TN/TN+FP

    TN = true negatives FP = False positives

  9. False Negative Rate

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

    False negative rate for both modalities - FN/FN+TP

    FN = False negatives TP = true positives

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

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

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

  11. Positive Predictive Values for PET-CT and PET-MRI

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

    Percent of true positive rate of diagnostic accuracy.

  12. Negative Predictive Values for PET-CT and PET-MRI

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

    Percent of true negative rate of diagnostic accuracy

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 8, 2013
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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