Clinical trial NCT00868582: The National Oncologic PET Registry
Official title: The National Oncologic PET Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Patients with proven or suspected cancer referred for NaF-18 PET to identify bone metastasis
Lead sponsor: American College of Radiology Imaging Network
Sponsor class: NETWORK
Collaborators: name: World Molecular Imaging Society (formerly Academy of Molecular Imaging)
First posted: 2009-03-25
Enrollment: 333000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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)

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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: PET Scans as ordered by treating physician per CMS frequency guidelines
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: American College of Radiology Imaging Network
state: Pennsylvania
Study officials:
affiliation: Virginia Commonwealth University
name: Bruce Hillner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hillner BE, Siegel BA, Liu D, Shields AF, Gareen IF, Hanna L, Stine SH, Coleman RE. Impact of positron emission tomography/computed tomography and positron emission tomography (PET) alone on expected management of patients with cancer: initial results from the National Oncologic PET Registry. J Clin Oncol. 2008 May 1;26(13):2155-61. doi: 10.1200/JCO.2007.14.5631. Epub 2008 Mar 24.
citation: Hillner BE, Siegel BA, Shields AF, Liu D, Gareen IF, Hunt E, Coleman RE. Relationship between cancer type and impact of PET and PET/CT on intended management: findings of the national oncologic PET registry. J Nucl Med. 2008 Dec;49(12):1928-35. doi: 10.2967/jnumed.108.056713. Epub 2008 Nov 7.
citation: Hillner BE, Siegel BA, Shields AF, Liu D, Gareen IF, Hanna L, Stine SH, Coleman RE. The impact of positron emission tomography (PET) on expected management during cancer treatment: findings of the National Oncologic PET Registry. Cancer. 2009 Jan 15;115(2):410-8. doi: 10.1002/cncr.24000.
citation: Hillner BE, Siegel BA, Shields AF, Duan F, Gareen IF, Hanna L, Coleman RE. Impact of dedicated brain PET on intended patient management in participants of the national oncologic PET Registry. Mol Imaging Biol. 2011 Feb;13(1):161-5. doi: 10.1007/s11307-010-0427-5.
citation: Hillner BE, Siegel BA, Hanna L, Shields AF, Duan F, Gareen IF, Quinn B, Coleman RE. Impact of 18F-FDG PET used after initial treatment of cancer: comparison of the National Oncologic PET Registry 2006 and 2009 cohorts. J Nucl Med. 2012 May;53(5):831-7. doi: 10.2967/jnumed.112.103911. Epub 2012 Mar 23.
citation: Hillner BE, Tosteson TD, Tosteson AN, Wang Q, Song Y, Onega T, Hanna LG, Siegel BA. Intended versus inferred management after PET for cancer restaging: analysis of Medicare claims linked to a coverage with evidence development registry. Med Care. 2013 Apr;51(4):361-7. doi: 10.1097/MLR.0b013e318287d860.
citation: Hillner BE, Tosteson AN, Tosteson TD, Wang Q, Song Y, Hanna LG, Siegel BA. Intended versus inferred care after PET performed for initial staging in the National Oncologic PET Registry. J Nucl Med. 2013 Dec;54(12):2024-31. doi: 10.2967/jnumed.113.123430. Epub 2013 Nov 12.
citation: Hillner BE, Siegel BA, Hanna L, Duan F, Shields AF, Coleman RE. Impact of 18F-fluoride PET in patients with known prostate cancer: initial results from the National Oncologic PET Registry. J Nucl Med. 2014 Apr;55(4):574-81. doi: 10.2967/jnumed.113.130005. Epub 2014 Feb 27.
citation: Hillner BE, Siegel BA, Hanna L, Duan F, Shields AF, Quinn B, Coleman RE. Impact of (18)F-Fluoride PET on Intended Management of Patients with Cancers Other Than Prostate Cancer: Results from the National Oncologic PET Registry. J Nucl Med. 2014 Jul;55(7):1054-61. doi: 10.2967/jnumed.113.135475. Epub 2014 May 12.
citation: Hillner BE, Siegel BA, Hanna L, Duan F, Quinn B, Shields AF. 18F-fluoride PET used for treatment monitoring of systemic cancer therapy: results from the National Oncologic PET Registry. J Nucl Med. 2015 Feb;56(2):222-8. doi: 10.2967/jnumed.114.150391. Epub 2015 Jan 15.