Evaluation of Rectal Cancer Treatment Response Using PET/MRI

NCT ID: NCT02233595

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-15
• Study Completion Date: 2018-01-28

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.

Conditions

Rectal Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adjuvant chemotherapy

Chemoradiation

Intervention Type: RADIATION

Interventions

Chemoradiation

Intervention Type: RADIATION

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 Univeristy of California, San Francisco (UCSF).
• Neoadjuvant chemoradiation prior to resection is planned..
• Eastern Cooperative Oncology Group (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 fluorodeoxyglucose (FDG) injection).
• Impaired renal function (CKD 4 or 5: estimated glomerular filtration rate (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Hope, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Imaging Center at China Basin

San Francisco, California, United States

Countries

United States

Other Identifiers

NCI-2015-00980

Identifier Type: REGISTRY

Identifier Source: secondary_id

144513

Identifier Type: -

Identifier Source: org_study_id