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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

333,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

15.1 years study duration

Study Start

First participant enrolled

May 1, 2006

Completed

2.9 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed

11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed

Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

14.6 years

First QC Date

March 24, 2009

Last Update Submit

August 21, 2020

Conditions

Cancer

Keywords

Patients with proven or suspected cancer referred for NaF-18 PET to identify bone metastasis

Outcome Measures

Primary Outcomes (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.
PET Scans as ordered by treating physician per CMS frequency guidelines

Study Arms (2)

FDG-PET

F-18 fluorodeoxyglucose (FDG-PET)

Other: PET scanning in cancer

NaF-18 PET

F-18 sodum-fluoride (NaF-18 PET)

Other: PET scanning in cancer

Interventions

PET scanning in cancerOTHER

Collection of institutional practice PET imaging data

Also known as: NOPR

FDG-PETNaF-18 PET

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Medicare beneficiaries who are referred for NaF-18 PET (the FDG-PET arm of NOPR has completed enrollment)

You may qualify if:

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

You may not qualify if:

NaF-18 PET for other (non-oncologic) indications.
NaF-18 PET performed as part of a clinical trial approved by CMS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American College of Radiology Imaging Network

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (10)

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.
PMID: 18362365RESULT
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.
PMID: 18997054RESULT
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.
PMID: 19016303RESULT
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.
PMID: 21080232RESULT
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.
PMID: 22448033RESULT
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.
PMID: 23481033RESULT
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.
PMID: 24221994RESULT
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.
PMID: 24578240RESULT
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.
PMID: 24819422RESULT
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.
PMID: 25593113RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

Bruce Hillner, MD
Virginia Commonwealth University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: NETWORK
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 25, 2009

Study Start

May 1, 2006

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

August 25, 2020

Record last verified: 2020-08

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

FDG-PET

NaF-18 PET

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

MeSH Terms

Conditions

Study Officials

Study Design

Study Record Dates

Locations