The National Oncologic PET Registry (NOPR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by American College of Radiology Imaging Network
Sponsor:
Collaborator:
Academy of Molecular Imaging
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT00868582
First received: March 24, 2009
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

The Centers for Medicare and Medicaid Services (CMS), as the Federal agency that administers the Medicare program, currently only pays for positron emission tomography (PET) scans for certain reasons and for certain types of cancer. CMS wants to 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 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
Cancer

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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150000
Study Start Date: May 2006
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Detailed Description:

The National Oncologic PET Registry (NOPR) was developed in response to the Centers for Medicare and Medicaid Services 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. 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 has 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 goal of the National Oncologic PET Registry is 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 the Centers for Medicare and Medicaid Services (CMS). Data are 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.

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 will 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 existing NOPR. The NaF-18 PET registry component of NOPR was activated for accrual on February 7, 2011.

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.

NOPR Update: Closing of FDG PET Data Collection (06/11/2013) - On June 11, 2013, CMS issued a final decision memorandum regarding FDG PET which calls for the end of the prospective data collection requirements under Coverage with Evidence Development (CED) for all oncologic indications for FDG-PET - this decision applies to the FDG-PET registry only. The NaF-PET registry remains open and will continue to accept new case registrations.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Medicare beneficiaries who are referred for PET

Criteria

Inclusion Criteria:

  • Except as noted by the following exclusions, all Medicare beneficiaries who are referred for PET for oncologic indications are eligible to be included in the NOPR

Exclusion Criteria:

  • PET for cancer type and specific indication currently designated as a covered service by the Medicare program.
  • PET for cancer type and specific indication currently designated as a non-covered service by the Medicare program (as of this version of the manual of operations, the following are designated as a non-covered service: breast cancer-diagnosis; breast cancer-initial staging of axillary lymph nodes; malignant melanoma-initial staging of regional lymph nodes).
  • PET performed as part of a clinical trial approved by CMS.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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@phila.acr.org   
Contact: Maria Oh    215-574-3160    moh@phila.acr.org   
Sponsors and Collaborators
American College of Radiology Imaging Network
Academy of Molecular Imaging
  More Information

Additional Information:
No publications provided

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT00868582     History of Changes
Other Study ID Numbers: NOPR
Study First Received: March 24, 2009
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by American College of Radiology Imaging Network:
All oncologic indications that are not currently reimbursable under Medicare

ClinicalTrials.gov processed this record on September 30, 2014