Clinical trial NCT02233595: Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Official title: Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rectal Adenocarcinoma
Keywords: MRI
PET
rectal cancer
adjuvant chemotherapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-09-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients with newly diagnosed rectal adenocarcinoma

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.


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.

Primary outcomes:
measure: change in SUVmax
timeFrame: 2 months
measure: tumor volume
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Imaging Center at China Basin
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Hope, MD
role: PRINCIPAL_INVESTIGATOR
References: