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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03353090
Other study ID # DTOM
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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