N/A
Completed N=15
PET-MRI in Diagnosing Patients With Colon or Rectal Cancer
Recurrent Colon Cancer · Recurrent Rectal Cancer · Stage IIA Colon Cancer · Stage IIA Rectal Cancer
Source: ClinicalTrials.gov NCT01807117 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: 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 — 1.9; 2.3; 1.3; 2.1 SUV max
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1.9; 2.3; 1.3; 2.1 | — |
| PRIMARY Maximum Standardized Uptake Value (SUVmax) in Physiologic Regions and FDG Avid Lesions in Participants Where PET-MRI Was Performed Prior to the PET-CT |
— | — |
| PRIMARY SUVmax in Which the PET-CT Was Performed Prior to the PET-MRI. |
3.0; 3.9 | — |
| PRIMARY SUVmax in Which the PET-MRI Was Performed Prior to the PET-CT |
5.9; 4.3 | — |
| PRIMARY SUVmax Ratio in Which the PET-CT Was Performed Prior to the PET-MRI |
2.0; 2.5 | — |
| PRIMARY SUVmax Ratio in Which the PET-MRI Was Performed Prior to the PET-CT |
2.7; 2.0 | — |
| PRIMARY True Positive Rate |
71; 71 | — |
| PRIMARY True Negative Rate |
100; 100 | — |
| PRIMARY False Negative Rate |
29; 14 | — |
| PRIMARY Proportion of Lesions Identified by PET-CT That Were Correctly Detected by PET-MRI |
26 | — |
| PRIMARY Positive Predictive Values for PET-CT and PET-MRI |
100; 100 | — |
| PRIMARY Negative Predictive Values for PET-CT and PET-MRI |
71.43; 83.33 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01807117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.