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

This study is currently recruiting participants.
Verified November 2017 by University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT02233595
First Posted: September 8, 2014
Last Update Posted: November 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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.

Condition Intervention
Rectal Adenocarcinoma Radiation: Chemoradiation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Rectal Cancer Treatment Response Using PET/MRI

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 20
Actual Study Start Date: October 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adjuvant chemotherapy Radiation: Chemoradiation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20 patients with newly diagnosed rectal adenocarcinoma
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233595


Locations
United States, California
UCSF Imaging Center at China Basin Recruiting
San Francisco, California, United States, 94107
Contact: Thomas Hope    415-353-1905    thomas.hope@ucsf.edu   
Principal Investigator: Thomas Hope         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Thomas Hope, MD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02233595     History of Changes
Other Study ID Numbers: Rectal-PETMRI-1
First Submitted: September 3, 2014
First Posted: September 8, 2014
Last Update Posted: November 21, 2017
Last Verified: November 2017

Keywords provided by University of California, San Francisco:
MRI
PET
rectal cancer
adjuvant chemotherapy

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases