OsteoarthritisNCT07784257
Diagnostic Accuracy of Triphasic Bone Scan and SPECT/CT in Foot and Ankle Osteoarthritis
An observational study of Osteoarthritis and Foot Osteoarthritis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Foot Osteoarthritis, Joint Diseases
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 20 Jan 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diagnostic Accuracy of Triphasic Bone Scan and SPECT/CT for the Evaluation of Foot and Ankle Osteoarthritis Using MRI as Reference Standard
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.
Read the detailed description
Osteoarthritis of the foot and ankle is a significant cause of chronic pain and functional impairment. Conventional radiography has limited sensitivity for early changes, while magnetic resonance imaging (MRI) is considered the reference standard for evaluating cartilage, bone marrow edema, and soft tissue structures.
Nuclear medicine techniques provide functional information about bone metabolism. Triphasic bone scan using technetium-99m methylene diphosphonate (99mTc-MDP) assesses perfusion, blood pool, and delayed skeletal uptake. However, planar imaging has limited spatial resolution and anatomical localization in the complex anatomy of the foot and ankle.
Hybrid SPECT/CT combines the functional data of SPECT with the precise anatomical localization of CT, improving diagnostic confidence and specificity. This study will evaluate the diagnostic accuracy of triphasic bone scan and SPECT/CT compared with MRI in patients with suspected foot and ankle osteoarthritis.
- Keywords
- SPECT/CT, Triphasic bone scan, Diagnostic accuracy
- Medical subject headings
- Osteoarthritis, Joint Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Identification of affected joints
Determination of the specific joints affected by osteoarthritis in the foot and ankle based on SPECT/CT and MRI findings.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Adel Ebraheem Abdelhameed, Assiut University
- Investigators
- Mohamed A Mekawy, prof, Study chair, assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784257
- Sponsor's protocol ID
- Foot-Ankle-OA-SPECTCT-2026
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30819397Expert 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.
PubMed 33153552van 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.
PubMed 39837711
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Triphasic Bone Scan and SPECT/CT for the Evaluation of Foot and Ankle Osteoarthritis Using MRI as Reference Standard
- ClinicalTrials.gov ID
- NCT07784257
- Acronym / sponsor ID
- Foot-Ankle-OA-SPECTCT-2026
- Keywords
- SPECT/CT, Triphasic bone scan, Diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Jan 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Osteoarthritis of the foot and ankle is a significant cause of chronic pain and functional impairment. Conventional radiography has limited sensitivity for early changes, while magnetic resonance imaging (MRI) is considered the reference standard for evaluating cartilage, bone marrow edema, and soft tissue structures.
Nuclear medicine techniques provide functional information about bone metabolism. Triphasic bone scan using technetium-99m methylene diphosphonate (99mTc-MDP) assesses perfusion, blood pool, and delayed skeletal uptake. However, planar imaging has limited spatial resolution and anatomical localization in the complex anatomy of the foot and ankle.
Hybrid SPECT/CT combines the functional data of SPECT with the precise anatomical localization of CT, improving diagnostic confidence and specificity. This study will evaluate the diagnostic accuracy of triphasic bone scan and SPECT/CT compared with MRI in patients with suspected foot and ankle osteoarthritis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of triphasic bone scan and SPECT/CT
Time frame: Baseline
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.
1 secondary outcome
Identification of affected joints
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 30819397Freeman 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.
- Background: PubMed 33153552Expert 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.
- Background: PubMed 39837711van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed A Mekawy, prof study chair
assiut
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Foot Osteoarthritis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira A Ebraheem, resident (01212838177 ext. 01212838177, aaabbb10121999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of triphasic bone scan and SPECT/CT (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07784257, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.