NCT07784257

Brief Summary

This cross-sectional study aims to assess the diagnostic accuracy of triphasic bone scintigraphy and SPECT/CT in evaluating foot and ankle osteoarthritis, using magnetic resonance imaging (MRI) as the reference standard, and to determine the affected joints.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Study Progress7%
Aug 2026Jan 2027

First Submitted

Initial submission to the registry

August 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 20, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2027

Expected
Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

Same day

First QC Date

August 20, 2026

Last Update Submit

August 22, 2026

Conditions

Keywords

SPECT/CTTriphasic bone scanDiagnostic accuracy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of triphasic bone scan and SPECT/CT

    Sensitivity, specificity, positive predictive value, and negative predictive value of triphasic bone scintigraphy and SPECT/CT for detecting foot and ankle osteoarthritis, using MRI as the reference standard.

    Baseline

Secondary Outcomes (1)

  • Identification of affected joints

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with chronic foot and/or ankle pain suspected of osteoarthritis referred to the Nuclear Medicine Unit at Assiut University Hospital who meet the eligibility criteria.

You may qualify if:

  • Age ≥ 18 years
  • Patients presenting with chronic foot and/or ankle pain suspected to be due to osteoarthritis
  • Clinical and/or radiographic suspicion of foot or ankle osteoarthritis

You may not qualify if:

  • Age \< 18 years
  • Previous surgery or joint replacement of the affected foot or ankle
  • Bone tumors or metastatic bone disease
  • Active osteomyelitis or septic arthritis
  • Inflammatory arthropathies (e.g., rheumatoid arthritis, psoriatic arthritis, gout)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Freeman LM, Donald Blaufox M. Seminars in Nuclear Medicine March 2019. Semin Nucl Med. 2019 Mar;49(2):83-84. doi: 10.1053/j.semnuclmed.2018.11.003. Epub 2018 Dec 6. No abstract available.

    PMID: 30819397BACKGROUND
  • Expert Panel on Musculoskeletal Imaging; Tafur M, Bencardino JT, Roberts CC, Appel M, Bell AM, Gyftopoulos S, Metter DF, Mintz DN, Morrison WB, Small KMS, Subhas N, Weissman BN, Yu JS, Kransdorf MJ. ACR Appropriateness Criteria(R) Chronic Foot Pain. J Am Coll Radiol. 2020 Nov;17(11S):S391-S402. doi: 10.1016/j.jacr.2020.09.015.

    PMID: 33153552BACKGROUND
  • van Hasselt AJ, de Vries AJ, de Zwart AD, Reininga IHF, Jutte PC, van Raaij TM. Diagnostic accuracy of 99mTc-HDP SPECT/CT and MRI for foot and ankle osteoarthritis (ProSPECT-trial): Study protocol. Foot Ankle Surg. 2025 Jul;31(5):443-447. doi: 10.1016/j.fas.2025.01.008. Epub 2025 Jan 19.

    PMID: 39837711BACKGROUND

MeSH Terms

Conditions

OsteoarthritisJoint Diseases

Condition Hierarchy (Ancestors)

ArthritisMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Mohamed A Mekawy, prof

    assiut

    STUDY CHAIR

Central Study Contacts

Amira A Ebraheem, resident

CONTACT

Mohamed A Mekawy, prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 25, 2026

Study Start

August 20, 2026

Primary Completion

August 20, 2026

Study Completion (Estimated)

January 20, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08