Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01254929
Other study ID # CAG00065R
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2010
Est. completion date March 2020

Study information

Verified date March 2020
Source Seattle Nuclear Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to compare 18F-Fluoride PET bone scans to traditional 99mTc-MDP bone scan to determine if one is better for diagnosing bone metastases.


Description:

Compare the diagnostic sensitivity, specificity, and accuracy of 18F-Fluoride PET bone scans versus traditional 99mTc-MDP bone scans for detecting bone metastases.

Determine if there is a significant change in clinical management between the two types of scans.

Measure and compare the number of equivocal or uncertain findings that would have caused additional testing, particularly additional imaging studies, to be performed for confirmation when using 18F-Fluoride PET bone scans versus 99mTc-MDP bone scans.

To quantify any adverse events resulting from either scan.

To perform subgroup analyses according to cancer cell type.


Recruitment information / eligibility

Status Completed
Enrollment 299
Est. completion date March 2020
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient has cancer

- Has been referred for evaluation of bone metastases

- Patient or patient's legal representative can understand and consent to enrollment in the study

- Must be 18 years or older

- Can remain still during the scan (approximately one hour)

- Patient has Medicare

Exclusion Criteria:

- Patient does not have Medicare

- Under the age of 18

- Cannot lie still for the necessary time

Study Design


Intervention

Device:
F-18 PET bone scan
Following the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan.
Tc-99m bone scan
Following the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera.

Locations

Country Name City State
United States Seattle Nuclear Medicine Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Seattle Nuclear Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accurate identification of bone metastases Individual subjects will be reviewed 6-12 months after their bone scans, utilizing all clinical and imaging data available, to determine diagnostic accuracy of each bone scan. Upon study completion (2-3 years)
Secondary Change in clinical management We will be sending out clinical questionnaires to the referring physicians, asking if the bone scan results helped and/or changed their clinical management. Cumulative data for each type of bone scan will be compared. Upon study completion (2-3 years)
Secondary Determine if F-18 PET bone scans lead to fewer follow-up imaging studies. The Tc-99m bone scans often give equivocal results that require other imaging studies, such as CT or MRI, for further evaluation. F-18 PET bone scans may give more definitive interpretations, and thus may lead to fewer follow-up studies being recommended/obtained. Upon study completion (2-3 years)
Secondary Quantify any adverse events from either type of scan. Any adverse events related to either type of scan will be recorded. Adverse events would be rare. Upon study completion (2-3 years)
Secondary Perform subgroup analyses according to cancer cell type. Both types of bone scans may be more or less accurate depending on the cancer cell type. We will attempt to address that question by performing subgroup analyses. Upon study completion (2-3 years)
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients