Hybrid PET/CT in Cancer Patients | NCT00396916

Studies
Hybrid PET/CT in Cancer Patients

NCT00396916

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Apr 11, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

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

Official Title

The Value of Novel Imaging Modality, Hybrid PET/CT, Using F18-Flurodeoxyglucose(FDG) in the Assessment of Cancer Patients. Impact of PET/CT on Clinical Management of Patients With Rising Tumor Markers and no Other Evidence of Disease and in Patients With Metastatic Cancer of Unknown Origin

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

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

Apr 10, 2007

Last Update Posted Date

Apr 11, 2007Estimated

Description Module

Brief Summary

The purpose of the present study is to assess the role of hybrid PET/CT imaging diagnosis of active malignancy in cancer patients with rising tumor markers after treatment and in the diagnosis of primary tumor in patients with metastatic cancer of unknown origin. The clinical impact of PET/CT in the management and treatment of these two groups of cancer patients will be evaluated

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 patient management

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cancer patients in complete remission after treatment, with serial elevation of serum tumor markers and negative CT or other conventional imaging test.
Patients with newly diagnosed metastatic cancer with unknown primary tumor
Glucose levels below 150-200
Patient signed informed consent

Exclusion Criteria:

Pregnant or lactating women
Patient unable or not willing to tolerate the test until its completion
One or more of the inclusion criteria is not fulfilled

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel Bar-Shalom, MD	Rambam Health Care Campus	Principal Investigator

Locations

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