NCT03298854

Brief Summary

To evaluate the diagnostic performance (sensitivity, specificity, Negative and positive predictive value) of skeletal co-registered SPECT/CT imaging in the detection of the etiology of low back pain in adolescent and adult patients

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Status
unknown

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 23, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

September 23, 2017

Last Update Submit

September 29, 2017

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (1)

  • The Diagnostic Performance of Skeletal 99mTc-MDP SPECT/CT in Patients with Low Back Pain

    evaluate the diagnostic performance (sensitivity, specificity, Negative and positive predictive value) of skeletal co-registered SPECT/CT imaging in the assessment of low back pain in adolescent and adult patients

    2years

Interventions

99mTc-MDP SPECT/CTDEVICE

Delayed whole body images, using Symbia-T-Siemens dual headed gamma camera, will be obtained 2-3 hours after injection of 15-25 mCi of Tc-99m MDP (Methylene diphosphonate) followed by SPECT images of the lumbar spine and pelvis.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients more than 18 years old
  • Suffering from mechanical low back pain, either acute (less than 4 weeks), sub-acute (4 weeks up to 3 months) or chronic (more than 3 months)

You may not qualify if:

  • Patients with known history of malignant disease
  • Patients with previous history of lumbar spine surgery
  • Patients with severe pain who cannot withstand the long duration of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed AH Mekkawy, professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Marwa F Abd ElHay

CONTACT

01022291658mohamedfathy1911995@gmail.com

Hemat AS Mahmoud, MD

CONTACT

01007532268hemat.ahmed2012@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident of Nuclear Medicine

Study Record Dates

First Submitted

September 23, 2017

First Posted

October 2, 2017

Study Start

November 1, 2017

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

October 2, 2017

Record last verified: 2017-09