PET/MRI as a Predictor of Response to Pre-op Chemoradiation in Resectable Rectal Cancer: a Pilot Study

Rectal Carcinoma Clinical Trial

Official title:

PET/MRI as a Predictor for Response to Preoperative Radiation Therapy and Chemotherapy in Resectable Rectal Cancer: a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751516
• Other study ID #: LCCC1225
• Status: Completed
• Start date: October 2012
• Est. completion date: March 4, 2018

Study information

• Verified date: January 2021
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and after surgery.

Description:

The primary purpose of this study is to determine the negative predictive value of PET/MRI for determining pathological complete response from neoadjuvant chemoradiation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 4, 2018
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Low-lying, low- to moderate-risk pathologically-confirmed rectal cancer (stage uT3n) or uT1-3N+
• Negative workup for distant disease
• > 18 years of age
• Pre-treatment workup completed including:
• history and physical
• CT or MRI of the abdomen and pelvis
• endoscopic tumor evaluation (biopsy, blood work to assess CEA and hematopoietic, renal and liver function)
• if female of child-bearing age, negative pregnancy test
• Recommendation to undergo preoperative concurrent chemoradiation, as determined by the treating physician
• Informed consent reviewed and signed

Exclusion Criteria:

• Not deemed a candidate for preoperative chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease
• Hemoglobin = 10.0 g/dL (transfusion allowed to achieve or maintain levels)
• ANC = 1,500/cubic mm³
• Platelet count = 100,000/mm³
• ALT and AST = 2.5 times upper level of normal (ULN)
• Alkaline phosphatase = 2.5 times ULN
• Total bilirubin = 1.5 times ULN
• Creatinine clearance < 50 mL/min
• Creatinine = 1.5 times ULN
• Not deemed a candidate for concurrent preoperative chemoradiation for social reasons, such as psychiatric illness
• Not deemed a surgical candidate
• Currently active second malignancy, except non-melanoma skin cancer, non-invasive bladder cancer, low risk adenocarcinoma of the prostate and carcinoma in situ of the cervix
• Previous pelvic radiation therapy
• History of severe reaction to gadolinium
• Inability to tolerate MRI (e.g., inability to lie flat for > 1 hour)
• Presence of a pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
• Body Mass Index (BMI) > 35
• Pregnant or lactating female

Related Conditions & MeSH terms

• Rectal Carcinoma
• Rectal Neoplasms

Locations

Country	Name	City	State
United States	University of North Carolina-Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology		4-8 weeks post-chemoradiation
Secondary	Recurrence-free survival		5 years
Secondary	Disease-specific survival		5 years
Secondary	Overall survival		5 years