PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery

Prospective Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Multimodality Management of Locally Advanced Primary Rectal Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004891

Enrollment

149

Registered

2003-01-27

Start date

1999-09-30

Completion date

Unknown

Last updated

2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer

Brief summary

RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patient's response to treatment. PURPOSE: This clinical trial is studying how well PET and CT scans detect residual or metastatic disease in patients with locally advanced primary rectal cancer that can be removed during surgery.

Detailed description

OBJECTIVES: * Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision. * Determine the accuracy of FDG-PET in detecting extrapelvic metastatic disease in primary rectal cancer patients considered operable on the basis of currently accepted diagnostic work-up, including abdominal CT scan and chest x-ray. OUTLINE: This is a diagnostic study conducted concurrently with multimodality management. Within 1-2 weeks prior to starting preoperative radiotherapy/chemotherapy, patients undergo baseline positron emission tomography (PET) imaging of the thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (FDG) IV followed 45 minutes later by PET imaging. Patients also undergo baseline CT imaging of the abdomen and pelvis. A CT scan of the chest is obtained if the prestudy chest x-ray is abnormal. Patients receive preoperative radiotherapy/chemotherapy. Within 4-6 weeks of completion of radiotherapy/chemotherapy, patients undergo repeat FDG-PET imaging and CT scan. Patients undergo surgical resection 1-2 weeks later. PROJECTED ACCRUAL: A total of 125 patients will be accrued for this study within 3 years.

Interventions

DRUGchemotherapy

PROCEDUREcomputed tomography

PROCEDUREconventional surgery

PROCEDUREneoadjuvant therapy

PROCEDUREpositron emission tomography

PROCEDUREradionuclide imaging

RADIATIONfludeoxyglucose F 18

RADIATIONradiation therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Primary resectable rectal cancer as determined by currently accepted diagnostic work-up, including CT scan and endorectal ultrasound (EUS) * Must meet criteria for preoperative radiotherapy and chemotherapy: * Bulky tumors and/or EUS evidence of T3-4 and/or N1 disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * No uncontrolled diabetes mellitus (i.e., greater than 175 mg/dL) * No intolerance of being inside PET scanner for duration of study * No vulnerable patients (e.g., mentally retarded or prisoners) PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics

Design outcomes

Primary

Measure	Time frame	Description
Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan	2 years	at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision

Secondary

Measure	Time frame	Description
Determine the accuracy of FDG-PET	2 years	in detecting extrapelvic metastatic disease in primary rectal cancer patients considered operable on the basis of currently accepted diagnostic work-up, including abdominal CT scan and chest x-ray.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026