This study is in progress, not accepting new patients

Evaluation of Rectal Cancer Treatment Response Using PET/MRI

a study on Colorectal Cancer Rectal Cancer

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:
Thomas Hope

Description

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.

Keywords

Rectal Adenocarcinoma MRI PET rectal cancer adjuvant chemotherapy Adenocarcinoma Rectal Neoplasms Chemoradiation

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Location

  • UCSF Imaging Center at China Basin
    San Francisco California 94107 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02233595
Lead Scientist
Thomas Hope
Study Type
Observational
Last Updated
June 26, 2018