NCT00979355

Brief Summary

A feasibility trial to evaluate the usefulness of a high efficiency camera (D-SPECT) as an imaging modality for general nuclear medicine applications such as oncology.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

1.1 years

First QC Date

September 17, 2009

Last Update Submit

June 13, 2019

Conditions

Detect Pathalogical Lesions

Keywords

Whole bodySPECT

Outcome Measures

Primary Outcomes (1)

  • A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to the ability to detect pathological lesions.

    12 month

Secondary Outcomes (1)

  • A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to image quality/resolution

    12 month

Interventions

GP-D-SPECTDEVICE

The D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large PMTs. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is referred to nuclear medicine department for a SPECT scan.
  • Written informed consent is obtained by a study investigator.

You may not qualify if:

  • Patient pregnancy (known or suspected).
  • Lack of written informed consent
  • Prisoner status
  • Patient under age 18 or over 80 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

Study Officials

  • MIGUEL GORENBERG, MD

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 14, 2019

Record last verified: 2019-06

Locations

IL(1)