- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00396916
Hybrid PET/CT in Cancer Patients
April 10, 2007 updated by: Rambam Health Care Campus
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
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
Study Overview
Study Type
Interventional
Enrollment
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel
- Rambam Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
the impact of the imaging modality on patient management
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
the impact of the imaging modality on patient management
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rachel Bar-Shalom, MD, Rambam Health Care Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Study Registration Dates
First Submitted
November 7, 2006
First Submitted That Met QC Criteria
November 7, 2006
First Posted (Estimate)
November 8, 2006
Study Record Updates
Last Update Posted (Estimate)
April 11, 2007
Last Update Submitted That Met QC Criteria
April 10, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- hybridCTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.