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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01254591
• Other study ID #: CDR0000689973
• Secondary ID: UCL-TUMOR-ANGIOG
• Status: Recruiting
• Phase: N/A
• First received: December 3, 2010
• Last updated: August 23, 2013
• Start date: November 2006

Study information

• Verified date: December 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Colorectal Cancer
• Colorectal Neoplasms
• Esophageal Cancer
• Esophageal Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• 18F-fluoromisonidazole

• fluorescence angiography

• laboratory biomarker analysis

Procedure:
• infrared thermography

• magnetic resonance imaging

• therapeutic conventional surgery

Radiation:
• [18F]-ML-10

• fludeoxyglucose F 18

• rubidium Rb-82

Locations

Country	Name	City	State
United Kingdom	University College Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
University College London (UCL) Cancer Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical, radiological, and pathological correlation			No
Primary	Prognosis (6-month, 1-year, 3-year, and 5-year mortality including local/distance recurrence rates)			No