NCT00824213

Brief Summary

The investigators propose to investigate the performance of the image reconstruction software with resolution recovery correction for bone SPECT studies. The investigators estimate that in only 30 minutes, using this new technique of collimator de-blurring, one could perform a fully 3-dimensional SPECT whole-body bone study, essentially obviating the necessity for doing planar bone studies. In the scope of the proposed project, the investigators group aims to test the hypothesis that one can perform a Tc-99m whole-body SPECT study in the same time as a regular routine planar bone study, with greater localization accuracy, and greater lesion detection. To establish a "gold standard" necessary to assess the performance of the SPECT bone scans, the investigators will compare number of malignant lesions detected in patients who are proven to have metastatic skeletal bone lesions on PET F-18 whole-body scans, with whole-body Tc-99m SPECT lesions. The investigators also propose to compare the detection of SPECT scans with standard planar bone scans. This will allow for two major comparisons (a) the accuracy of SPECT bone studies compared to planar bone studies, and (b) the accuracy of SPECT bone scans compared to F-18 PET studies. Most prior studies purporting to show the superiority of F-18 bone scans to Tc-99 bone scans were done only against either planar scans or a combination of planar scans and partial SPECT studies over the spine. We anticipate that F-18 bone scans, due to the higher counting statistics of PET agents, will show more lesions than SPECT, but the exact increase in sensitivity has never been compared to whole-body SPECT scans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2016

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

7.6 years

First QC Date

January 14, 2009

Last Update Submit

March 1, 2017

Conditions

Keywords

Whole Body SPECT imaging

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Over the last 3-4 months, 60 anonymized patient studies were acquired using concurrent acquisition protocol with 20s, 15s, 10s, and 5s per view and with a total of 64 views (32 views/head). The data from these studies will be used to optimize the reconstruction process and establish the definitive reconstruction parameters to be used in the current study. We plan to accrue a total of 25 subjects with suspected bone metastases who will undergo planar bone scintigraphy, bone SPECT and a Na18F whole-body bone PET scan.

You may qualify if:

  • Patients with a prior history of prostate cancer and
  • clinically suspected bone metastases based on symptoms, radiological examinations or abnormal biochemistry results

You may not qualify if:

  • Inability to consent to participate in the research study.
  • Inability to lie supine for a period of at least 45 minutes.
  • Inability to travel to the examination site to undergo the PET/CT examination.
  • ECOG/WHO performance status ≥ 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 1L3, Canada

Location

Vancouver Coastal Health Research Institute

Vancouver, British Columbia, V5Z 3P1, Canada

Location

Study Officials

  • Anna Celler, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Philip Cohen

    University of British Columbia

    STUDY DIRECTOR
  • Francois Benard

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 16, 2009

Study Start

January 1, 2009

Primary Completion

August 10, 2016

Study Completion

August 10, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations