The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The National Oncologic PET Registry (NOPR)

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.
 
ClinicalTrials.gov Identifier: NCT00868582
Recruitment Status : Unknown
Verified August 2020 by American College of Radiology Imaging Network.
Recruitment status was:  Active, not recruiting
First Posted : March 25, 2009
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
World Molecular Imaging Society (formerly Academy of Molecular Imaging)
Information provided by (Responsible Party):
American College of Radiology Imaging Network

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The Centers for Medicare & Medicaid Services (CMS), as the Federal agency that administers the Medicare program, only pays for positron emission tomography (PET) scans in patients with cancer for certain reasons and for certain types of cancer. This study was developed to help CMS determine if they should pay for PET scans for additional reasons and additional types of cancer. In order to collect the information needed to decide which other types of cancer should be covered by Medicare, CMS will provide payment for the otherwise non-covered PET scans of patients who are properly registered with the National Oncologic PET Registry (NOPR). This information will then be analyzed to determine the effect PET scans had on the way physicians planned to treat their patients.

Condition or disease Intervention/treatment
Cancer Other: PET scanning in cancer

Detailed Description:

The National Oncologic PET Registry (NOPR) was developed in response to the Centers for Medicare & Medicaid Services (CMS) proposal to expand coverage for positron emission tomography with F-18 fluorodeoxyglucose (FDG-PET) to include cancers and indications not presently eligible for Medicare reimbursement. Under this coverage with evidence development (CED) program, Medicare reimbursement for these cancers can be obtained if the patient's referring physician and the provider submit data to a clinical registry to assess the impact of PET on cancer patient management. The NOPR implemented this registry for CMS. The NOPR is sponsored by the World Molecular Imaging Society (formerly the Academy of Molecular Imaging), and managed by the American College of Radiology through the American College of Radiology Imaging Network.

The original goal of the National Oncologic PET Registry was to assess the effect of positron emission tomography with F-18 fluorodeoxyglucose (FDG-PET) on referring physicians' plans of intended patient management for those cancers and indications not currently eligible for reimbursement from CMS. Data were collected from the referring physician before and after the PET study. If complete and timely data are reported to the NOPR within 30 days of the PET scan, the PET facility and interpreting physician (nuclear physician/radiologist) are eligible for reimbursement by CMS. Based in part on data obtained from the NOPR, CMS expanded coverage for FDG-PET in patients with cancer on April 3, 2009 and further expanded coverage on June 11, 2013. Specifically, on June 11, 2013, CMS issued a final decision memorandum ending the prospective data collection requirements under CED for all oncologic indications for FDG-PET. Overall accrual to the FDG-PET registry was nearly 288,000 scans.

On February 26, 2010, CMS announced its decision to cover the use NaF-18 PET to identify bone metastasis. Under this new policy, the use of NaF-18 PET would be covered only under an approved (CED) program. The NOPR obtained CMS approval to develop a registry for NaF-18 as an amendment to the then-existing NOPR for FDG-PET. The NaF-18 PET registry component of NOPR was activated for accrual on February 7, 2011. Estimated total accrual to the NaF-PET registry is 45,000 cases.

As with the registry for FDG-PET, the goal of the NaF-18 PET registry component is to assess the impact of this imaging examination on referring physicians' plans of intended management of patients with known or suspected osseous metastatic disease. Data are collected from the referring physician before and after the PET study, as well as from the interpreting physician. If complete and timely data are reported to the NOPR within 30 days of the PET scan, the PET facility and interpreting physician (nuclear physician/radiologist) are eligible for reimbursement by CMS.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 333000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The National Oncologic PET Registry
Study Start Date : May 2006
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
FDG-PET
F-18 fluorodeoxyglucose (FDG-PET)
 Other: PET scanning in cancer
Collection of institutional practice PET imaging data
Other Name: NOPR
NaF-18 PET
F-18 sodum-fluoride (NaF-18 PET)
 Other: PET scanning in cancer
Collection of institutional practice PET imaging data
Other Name: NOPR


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To assess the effect of PET on referring physicians' plans of intended patient management of patients with cancer types eligible for inclusion in the National Oncologic PET Registry. [ Time Frame: PET Scans as ordered by treating physician per CMS frequency guidelines ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Medicare beneficiaries who are referred for NaF-18 PET (the FDG-PET arm of NOPR has completed enrollment)
Criteria

Inclusion Criteria:

  • All Medicare beneficiaries who are referred for NaF-18 PET to identify bone metastasis are eligible to be included in the NOPR.

Exclusion Criteria:

  • NaF-18 PET for other (non-oncologic) indications.
  • NaF-18 PET performed as part of a clinical trial approved by CMS.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00868582


Locations
Layout table for location information
United States, Pennsylvania
American College of Radiology Imaging Network
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
American College of Radiology Imaging Network
World Molecular Imaging Society (formerly Academy of Molecular Imaging)
Investigators
Layout table for investigator information
Principal Investigator: Bruce Hillner, MD Virginia Commonwealth University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT00868582    
Other Study ID Numbers: NOPR
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Keywords provided by American College of Radiology Imaging Network:
Patients with proven or suspected cancer referred for NaF-18 PET to identify bone metastasis