Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Positron Emission Tomography/Computed Tomography Scanning Before Surgery in Patients With Non-Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer, Esophageal Cancer, or Head and Neck Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01254591
First received: December 3, 2010
Last updated: August 23, 2013
Last verified: December 2010
  Purpose

RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT) scanning before surgery, may help measure the extent of disease.

PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.


Condition Intervention
Breast Cancer
Colorectal Cancer
Esophageal Cancer
Head and Neck Cancer
Lung Cancer
Other: 18F-fluoromisonidazole
Other: fluorescence angiography
Other: laboratory biomarker analysis
Procedure: infrared thermography
Procedure: magnetic resonance imaging
Procedure: therapeutic conventional surgery
Radiation: [18F]-ML-10
Radiation: fludeoxyglucose F 18
Radiation: rubidium Rb-82

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Tumor Angiogenesis in Non-Small Cell Lung (NSCLC), Colorectal, Breast, Esophageal, Head and Neck Cancer: Radiology-Pathology and Prognostic Correlation

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical, radiological, and pathological correlation [ Designated as safety issue: No ]
  • Prognosis (6-month, 1-year, 3-year, and 5-year mortality including local/distance recurrence rates) [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: November 2006
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine the ability of preoperative fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning in assessing tumor angiogenesis in patients with potentially operable non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.
  • To determine the ability of preoperative fludeoxyglucose F 18 PET/CT scanning in assessing prognosis by means of measuring angiogenesis in these patients.

OUTLINE: All patients undergo fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning for staging, tumor perfusion measurement/angiogenesis, and glucose metabolism. If staging confirms operable disease, then the patient proceeds to surgery as planned. Resected tumor tissue samples are examined for tumor angiogenesis in the various cancer types.

Some patients undergo a half-dose of rubidium Rb-82 or 18F-fluoromisonidazole or [18F]-ML-10 PET scan or fluorescence angiography. Patients with colorectal cancer undergo a CT scan for perfusion of the tumor after the staging PET/CT. Patients with breast cancer undergo infrared thermometry as well as a MRI scan for staging and to predict angiogenesis.

After completion of study therapy, patients are followed up at 1 month and then every 6 months for 5 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer

    • Potentially operable disease
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Not specified
  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254591

Locations
United Kingdom
University College Hospital Recruiting
London, England, United Kingdom, NW1 2BU
Contact: Contact Person    44-207-631-1066    peter.ell@uclh.nhs.uk   
Sponsors and Collaborators
University College London (UCL) Cancer Institute
Investigators
Principal Investigator: Peter Ell, MD University College London Hospitals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01254591     History of Changes
Other Study ID Numbers: CDR0000689973, UCL-TUMOR-ANGIOGENESIS, EU-21086
Study First Received: December 3, 2010
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IA non-small cell lung cancer
stage IB non-small cell lung cancer
stage IIA non-small cell lung cancer
stage IIB non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage I colon cancer
stage IIA colon cancer
stage IIB colon cancer
stage IIC colon cancer
stage IIIA colon cancer
stage I rectal cancer
stage IIA rectal cancer
stage IIB rectal cancer
stage IIC rectal cancer
stage IIIA rectal cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage I hypopharyngeal cancer
stage II hypopharyngeal cancer
stage III hypopharyngeal cancer
stage I laryngeal cancer
stage II laryngeal cancer
stage III laryngeal cancer
stage I lip and oral cavity cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Breast Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Rectal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Thoracic Neoplasms
Fluorodeoxyglucose F18
Fluoromisonidazole
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014