The Role of the Vagus Nerve in Tumor-to-Brain Communicati... | NCT00397124

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

NCT00397124

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Nov 8, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

PET/CT imaging

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 7, 2006

First Submission Date that Met QC Criteria

Nov 7, 2006

First Posted Date

Nov 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2006

Last Update Posted Date

Nov 8, 2006Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
PET/CT imaging	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the impact of the imaging modality on patients management

Secondary Outcomes

Measure	Description	Time Frame
the impact of the imaging modality on patients management

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alex Frenkel, Ph.D	Contact	972-4-8543009		a_frenkel@rambam.health.gov.il

Overall Officials

Name	Affiliation	Role
Ora Israel, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Medical Center	Recruiting	Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided