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

Sponsor
UNC Lineberger Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01751516
Collaborator
(none)
8
Enrollment
1
Location
65.1
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    8 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    PET/MRI as a Predictor for Response to Preoperative Radiation Therapy and Chemotherapy in Resectable Rectal Cancer: a Pilot Study.
    Actual Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Aug 1, 2014
    Actual Study Completion Date :
    Mar 4, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology [4-8 weeks post-chemoradiation]

    Secondary Outcome Measures

    1. Recurrence-free survival [5 years]

    2. Disease-specific survival [5 years]

    3. Overall survival [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of North Carolina-Chapel Hill Chapel Hill North Carolina United States 27599

    Sponsors and Collaborators

    • UNC Lineberger Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Joel E Tepper, MD, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UNC Lineberger Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01751516
    Other Study ID Numbers:
    • LCCC1225
    First Posted:
    Dec 18, 2012
    Last Update Posted:
    Jan 29, 2021
    Last Verified:
    Jan 1, 2021
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Jan 29, 2021