PET/MRI as a Predictor of Response to Pre-op Chemoradiation in Resectable Rectal Cancer: a Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01751516
Recruitment Status : Active, not recruiting
First Posted : December 18, 2012
Last Update Posted : November 12, 2018
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

December 13, 2012
December 18, 2012
November 12, 2018
October 2012
August 2014   (Final data collection date for primary outcome measure)
Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology [ Time Frame: 4-8 weeks post-chemoradiation ]
Same as current
Complete list of historical versions of study NCT01751516 on Archive Site
  • Recurrence-free survival [ Time Frame: 5 years ]
  • Disease-specific survival [ Time Frame: 5 years ]
  • Overall survival [ Time Frame: 5 years ]
Same as current
Not Provided
Not Provided
PET/MRI as a Predictor of Response to Pre-op Chemoradiation in Resectable Rectal Cancer: a Pilot Study
PET/MRI as a Predictor for Response to Preoperative Radiation Therapy and Chemotherapy in Resectable Rectal Cancer: a Pilot Study.
This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and after surgery.
The primary purpose of this study is to determine the negative predictive value of PET/MRI for determining pathological complete response from neoadjuvant chemoradiation.
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
UNC Hospitals
Rectal Carcinoma
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
October 2019
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Low-lying, low- to moderate-risk pathologically-confirmed rectal cancer (stage uT3n) or uT1-3N+
  • Negative workup for distant disease
  • > 18 years of age
  • Pre-treatment workup completed including:
  • history and physical
  • CT or MRI of the abdomen and pelvis
  • endoscopic tumor evaluation (biopsy, blood work to assess CEA and hematopoietic, renal and liver function)
  • if female of child-bearing age, negative pregnancy test
  • Recommendation to undergo preoperative concurrent chemoradiation, as determined by the treating physician
  • Informed consent reviewed and signed

Exclusion Criteria:

  • Not deemed a candidate for preoperative chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease
  • Hemoglobin ≤ 10.0 g/dL (transfusion allowed to achieve or maintain levels)
  • ANC ≤ 1,500/cubic mm³
  • Platelet count ≤ 100,000/mm³
  • ALT and AST ≥ 2.5 times upper level of normal (ULN)
  • Alkaline phosphatase ≥ 2.5 times ULN
  • Total bilirubin ≥ 1.5 times ULN
  • Creatinine clearance < 50 mL/min
  • Creatinine ≥ 1.5 times ULN
  • Not deemed a candidate for concurrent preoperative chemoradiation for social reasons, such as psychiatric illness
  • Not deemed a surgical candidate
  • Currently active second malignancy, except non-melanoma skin cancer, non-invasive bladder cancer, low risk adenocarcinoma of the prostate and carcinoma in situ of the cervix
  • Previous pelvic radiation therapy
  • History of severe reaction to gadolinium
  • Inability to tolerate MRI (e.g., inability to lie flat for > 1 hour)
  • Presence of a pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
  • Body Mass Index (BMI) > 35
  • Pregnant or lactating female
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
Not Provided
Principal Investigator: Joel E Tepper, MD University of North Carolina, Chapel Hill
UNC Lineberger Comprehensive Cancer Center
November 2018