Evaluation of Rectal Cancer Treatment Response Using PET/MRI

Rectal Adenocarcinoma Clinical Trial

— Rectal PET/MRI  

Official title:

Evaluation of Rectal Cancer Treatment Response Using PET/MRI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02233595
• Other study ID #: 144513
• Secondary ID: NCI-2015-00980
• Status: Terminated
• Start date: October 15, 2014
• Est. completion date: January 28, 2018

Study information

• Verified date: August 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 28, 2018
• Est. primary completion date: January 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Adenocarcinoma
• Rectal Neoplasms

Intervention

Radiation:
• Chemoradiation

Locations

Country	Name	City	State
United States	UCSF Imaging Center at China Basin	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in SUVmax	To determine whether percent change in SUVmax correlates with the extent of pathologic primary tumor response	2 months
Primary	tumor volume	To determine whether percent change in tumor volume correlates with the extent of pathologic primary tumor response	2 months