NCT03353090

Brief Summary

Bone scintigraphy is currently a reference test in the initial staging of cancer. Bone scintigraphy historically consists in a planar whole-body scintigraphy (WBS). SPECT/CT has been shown to dramatically reduce the proportion of inconclusive results and increase the specificity of bone scintigraphy. Therefore, in most of nuclear médicine centers, the usual protocol for staging of bone metastases consists in a whole-body planar acquisition followed, if needed, by a targeted SPECT/CT to characterize suspicious or equivocal uptakes seen on WBS. The aim of this study is to assess the incremental diagnostic utility of a systematic double-bed SPECT/CT acquisition for bone scintigraphy in initial staging of cancer patients compared with the conventional "WBS plus single-bed targeted SPECT/CT" strategy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 10, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

November 10, 2017

Last Update Submit

November 22, 2017

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

  • Diagnostic impact of a systematic double SPECT/CT as compared to a oriented single-bed SPECT/CT bone scintigraphy for staging of malignancies with bone scintigraphy

    day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients

You may qualify if:

  • Patients referred for bone scintigraphy for initial staging of biopsy proven malignancy.

You may not qualify if:

  • monoclonal gammapathy
  • patients under 18 years of age
  • Technical issues not allowing a double-bed SPECT/CT acquisition
  • double bed SPECT/CT acquisition not centered from the upper cervical spine to the proximal femora

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 27, 2017

Study Start

October 10, 2016

Primary Completion

December 10, 2016

Study Completion

December 10, 2016

Last Updated

November 27, 2017

Record last verified: 2017-11

Locations

FR(1)