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The National Oncologic PET Registry (NOPR)

This study is currently recruiting participants.
Verified January 2016 by American College of Radiology Imaging Network
Sponsor:
ClinicalTrials.gov Identifier:
NCT00868582
First Posted: March 25, 2009
Last Update Posted: January 18, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
World Molecular Imaging Society (formerly Academy of Molecular Imaging)
Information provided by (Responsible Party):
American College of Radiology Imaging Network
  Purpose
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 Intervention
Cancer Other: PET scanning in cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The National Oncologic PET Registry

Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 333000
Study Start Date: May 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
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


Contacts
Contact: Bruce Hillner, MD 804-828-5129 Hillner@vcu.edu
Contact: Barry Siegel, MD 314-362-2809 Siegelb@mir.wustl.edu

Locations
United States, Pennsylvania
American College of Radiology Imaging Network Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Joy A Brown    215-717-0859    jbrown@acr.org   
Contact: Martha Heckel    215-574-3169    mheckel@acr.org   
Sponsors and Collaborators
American College of Radiology Imaging Network
World Molecular Imaging Society (formerly Academy of Molecular Imaging)
Investigators
Principal Investigator: Bruce Hillner, MD Virginia Commonwealth University
  More Information

Additional Information:
Publications:

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT00868582     History of Changes
Other Study ID Numbers: NOPR
First Submitted: March 24, 2009
First Posted: March 25, 2009
Last Update Posted: January 18, 2016
Last Verified: January 2016

Keywords provided by American College of Radiology Imaging Network:
Patients with proven or suspected cancer referred for NaF-18 PET to identify bone metastasis