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Evaluation of Rectal Cancer Treatment Response Using PET/MRI (Rectal PET/MRI)

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.
ClinicalTrials.gov Identifier: NCT02233595
Recruitment Status : Active, not recruiting
First Posted : September 8, 2014
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date September 3, 2014
First Posted Date September 8, 2014
Last Update Posted Date June 28, 2018
Actual Study Start Date October 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2014)
  • change in SUVmax [ Time Frame: 2 months ]
    To determine whether percent change in SUVmax correlates with the extent of pathologic primary tumor response
  • tumor volume [ Time Frame: 2 months ]
    To determine whether percent change in tumor volume correlates with the extent of pathologic primary tumor response
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02233595 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Official Title Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Brief Summary The investigators will be using the combination of FDG-PET and multiparametric MRI in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 20 patients with newly diagnosed rectal adenocarcinoma
Condition Rectal Adenocarcinoma
Intervention Radiation: Chemoradiation
Study Groups/Cohorts Adjuvant chemotherapy
Intervention: Radiation: Chemoradiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 26, 2018)
7
Original Estimated Enrollment
 (submitted: September 5, 2014)
20
Estimated Study Completion Date December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • A diagnosis of histopathologically confirmed rectal adenocarcinoma.
  • Locally advanced disease as determined by ERUS or pelvic MRI. Endoscopy reports should clearly state both the T and N stage.
  • Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation.
  • Age ≥18.
  • Ability to understand a written informed consent document and the willingness to sign it.
  • Tumor must be determined to be surgically resectable. Surgical resection is planned to take place at UCSF.
  • Neoadjuvant chemoradiation prior to resection is planned..
  • ECOG performance status of 0, 1 or 2.

Exclusion Criteria:

  • ERUS tumor state of T1.
  • Radiographic evidence of metastatic disease
  • Weight in excess of limitations of the scanner or girth that prohibits entry into the bore of the PET/CT scanner due to size.
  • Any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.)
  • Prior receipt of any therapy, including local excision, radiation or chemotherapy, for the diagnosed rectal adenocarcinoma.
  • Prior history of pelvic radiation.
  • Uncontrolled hyperglycemia (defined as inability to achieve a glucose of <250 mg/dL at time of FDG injection).
  • Impaired renal function (CKD 4 or 5: eGFR < 30 mLs/min), which is a contraindication to gadolinium containing contrast.
  • Known allergy to gadolinium containing contrast agents.
  • Contraindication to use of fluoropyrimidines as a radiosensitizing agent.
  • Pregnancy or nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization. This is because of the potential teratogenic effects of the involved imaging modalities, radiation, and chemotherapy.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02233595
Other Study ID Numbers Rectal-PETMRI-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: Thomas Hope, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date June 2018