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

August 23, 2013 updated by: University College London (UCL) Cancer Institute

Tumor Angiogenesis in Non-Small Cell Lung (NSCLC), Colorectal, Breast, Esophageal, Head and Neck Cancer: Radiology-Pathology and Prognostic Correlation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, NW1 2BU
        • Recruiting
        • University College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical, radiological, and pathological correlation
Prognosis (6-month, 1-year, 3-year, and 5-year mortality including local/distance recurrence rates)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College London (UCL) Cancer Institute

Investigators

  • Principal Investigator: Peter Ell, MD, University College London Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Anticipated)

August 1, 2013

Study Completion

December 8, 2022

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 3, 2010

First Posted (Estimate)

December 6, 2010

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000689973
  • UCL-TUMOR-ANGIOGENESIS
  • EU-21086

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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