Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients

Bone Metastases Clinical Trial

— DTOM  

Official title:

Incremental Diagnostic Utility of Systematic Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353090
• Other study ID #: DTOM
• Status: Completed
• Phase: N/A
• First received: November 10, 2017
• Last updated: November 22, 2017
• Start date: October 10, 2016
• Est. completion date: December 10, 2016

Study information

• Verified date: November 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Images are interpreted by two nuclear medicine physicians in a 3-step procedure and by consensus. Firstly,only WBS planar images are considered. Secondly, a single-bed SPECT/CT chosen based on planar images is used if WBS demonstrated any equivocal or suspicious uptake.

Finally, WBS and double-bed SPECT/CT images are used for interpretation.

A per-lesion, a per-anatomical region and a per-patient analysis is performed. At each step, lesions, regions and diagnostic conclusions are classified using a 3-level scale, as negative for malignancy, equivocal or suspicious for metastasis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 10, 2016
• Est. primary completion date: December 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bone Metastases

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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