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The Role of the Vagus Nerve in Tumor-to-Brain Communication in Lung Cancer Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00397124
First Posted: November 8, 2006
Last Update Posted: November 8, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  Purpose
the aim of this study is to measure brain metabolism in patients with lung cancer.FDG uptake in the brain in patients with malignant tumors will be compared to the amount of tracer activity found in patients who have benign pulmonary process. if differences between the brain uptake of FDG in the two groups will be found, further assessment will be performed in order to evaluate if such differences could be attributed and specifically localized to the brain regions innervated by the vagus

Condition Intervention
Lung Cancer Device: PET/CT imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Does the Vagus Nerve Play a Role in Tumor-to-Brain Communication? a Preliminary Study in Patients With Newly Diagnosed Lung Cancer

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • the impact of the imaging modality on patients management

Secondary Outcome Measures:
  • the impact of the imaging modality on patients management

Estimated Enrollment: 40
Study Start Date: April 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with SPN referred for routine whole body FDG-PET imaging
  • patients with NSCLC and patients with no evidence of lung cancer on further follow up

Exclusion Criteria:

  • patients with a clinical history of vagotomy, abdominal surgery. brain tumor, brain trauma or CVA. or those with a systemic inflammatory disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397124


Contacts
Contact: Alex Frenkel, Ph.D 972-4-8543009 a_frenkel@rambam.health.gov.il

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Alex Frenkel, Ph.D    972-4-8543009    a_frenkel@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ora Israel, MD Rambam Health Care Campus
  More Information

ClinicalTrials.gov Identifier: NCT00397124     History of Changes
Other Study ID Numbers: vagusCTIL
First Submitted: November 7, 2006
First Posted: November 8, 2006
Last Update Posted: November 8, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases