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

Sponsor
University College London (UCL) Cancer Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT01254591
Collaborator
(none)
500
1

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • 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
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
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
Study Start Date :
Nov 1, 2006
Anticipated Primary Completion Date :
Aug 1, 2013

Outcome Measures

Primary Outcome Measures

  1. Clinical, radiological, and pathological correlation []

  2. Prognosis (6-month, 1-year, 3-year, and 5-year mortality including local/distance recurrence rates) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University College Hospital London England United Kingdom NW1 2BU

Sponsors and Collaborators

  • University College London (UCL) Cancer Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01254591
Other Study ID Numbers:
  • CDR0000689973
  • UCL-TUMOR-ANGIOGENESIS
  • EU-21086
First Posted:
Dec 6, 2010
Last Update Posted:
Aug 26, 2013
Last Verified:
Dec 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2013