OsteoarthritisNCT03290807
The Role of Tc 99m MDP SPECT/CT in Osteoarthritis
An observational study of Osteoarthritis, run by Assiut University.
Trial summary
Evaluation of the diagnostic value of SPECT/CT in patients with knee and/or hip OA, whether it is related to clinical findings and it could reflect clinical disease activity, and to determine the usefulness of SPECT/CT in early detection of OA. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- SPECT/CT
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Adult patient above 30 years old. * Clinically diagnosed osteoarthritis before treatment. * Patient with refractory active osteoarthritis (not responding to treatment). * Ability to sleep in fixed position for about 25 minutes * Ability to provide informed consent.
Who may be able to join
- Adult patient above 30 years old.
- Clinically diagnosed osteoarthritis before treatment.
- Patient with refractory active osteoarthritis (not responding to treatment).
- Ability to sleep in fixed position for about 25 minutes
- Ability to provide informed consent.
Who cannot join
- Patient with resolved osteoarthritis.
- patient with other disease in joints:
- Avascular necrosis
- Stress fracture
- Neuropathic pain
Trial locations and contacts
No sites are listed yet.
About this study
Evaluation of the diagnostic value of SPECT/CT in patients with knee and/or hip OA, whether it is related to clinical findings and it could reflect clinical disease activity, and to determine the usefulness of SPECT/CT in early detection of OA.
Read the detailed description
Osteoarthritis (OA) is a slowly developing chronic degenerative joint disease that progresses over years. After the classification and reporting of OA were established by American College of Rheumatology in 1986, the diagnosis has depended on the patients' symptoms and supported by plain radiographic findings.
Since X-ray image has a discrepancy with clinical findings, the therapeutic modalities tend to depend on the clinical symptoms, rather than the objective imaging findings.
MRI is a non-invasive and a very sensitive tool in detecting the early bony change such as bone marrow oedema, but it has some limitation in that it may have false positive or false negative results in the detection of the patella-femoral (PF) lesions. Bone scintigraphy is relatively sensitive because it reflects the early physiological changes of joints. But its image is planar that it cannot give enough information for the anatomic localization, and the image is overlapped.
To compensate for the defects of these imaging methods, bone single photon emission computed tomography (SPECT) has emerged as useful imaging tools in the diagnosis of OA.
Based upon the fact that subchondral bony changes precede joint space narrowing in OA, bone SPECT seems to be a very useful tool in early OA, reflecting the early bony changes.
The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional imaging (SPECT), which represents a relevant improvement in preoperative diagnosis and follow-up after procedures.
- Conditions
- Osteoarthritis
- Being tested
- SPECT/CT
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT/CTDevice
Combined single photon emission computerized tomography and conventional computerized tomography (SPECT/CT) is a hybrid imaging modality, which combines a 3D bone scintigraphy (SPECT) and a conventional CT into one imaging procedure. The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional imaging (SPECT)
What is being measured
The primary outcome is the main question the study is designed to answer.
Detecting different pattern of osseous MDP uptake in patient with osteoarthritis in hip joints and/or knees in relation to clinical and simple radiographic findings.
Osteoarthritic patients will be examined with 99mTc-methylene diphosphonate (MDP) bone SPECT, the sites of uptake will be localized.
Simple radiograph and physical examination will be assessed.The relationships between clinical findings, simple radiographic findings and the intensity of uptake in SPECT will be analyzed.
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 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma El-Zahraa Mostafa Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290807
- Sponsor's protocol ID
- SPECT/CT in osteoarthritis
- Status last verified
- Sep 2017
- First submitted
- 18 Sep 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Tc 99m MDP SPECT/CT in Osteoarthritis
- ClinicalTrials.gov ID
- NCT03290807
- Acronym / sponsor ID
- SPECT/CT in osteoarthritis
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 25 Sep 2017 (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.
Evaluation of the diagnostic value of SPECT/CT in patients with knee and/or hip OA, whether it is related to clinical findings and it could reflect clinical disease activity, and to determine the usefulness of SPECT/CT in early detection of OA.
Detailed description
Osteoarthritis (OA) is a slowly developing chronic degenerative joint disease that progresses over years. After the classification and reporting of OA were established by American College of Rheumatology in 1986, the diagnosis has depended on the patients' symptoms and supported by plain radiographic findings.
Since X-ray image has a discrepancy with clinical findings, the therapeutic modalities tend to depend on the clinical symptoms, rather than the objective imaging findings.
MRI is a non-invasive and a very sensitive tool in detecting the early bony change such as bone marrow oedema, but it has some limitation in that it may have false positive or false negative results in the detection of the patella-femoral (PF) lesions. Bone scintigraphy is relatively sensitive because it reflects the early physiological changes of joints. But its image is planar that it cannot give enough information for the anatomic localization, and the image is overlapped.
To compensate for the defects of these imaging methods, bone single photon emission computed tomography (SPECT) has emerged as useful imaging tools in the diagnosis of OA.
Based upon the fact that subchondral bony changes precede joint space narrowing in OA, bone SPECT seems to be a very useful tool in early OA, reflecting the early bony changes.
The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional imaging (SPECT), which represents a relevant improvement in preoperative diagnosis and follow-up after procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Adult patient above 30 years old. * Clinically diagnosed osteoarthritis before treatment. * Patient with refractory active osteoarthritis (not responding to treatment). * Ability to sleep in fixed position for about 25 minutes * Ability to provide informed consent.
Key inclusion criteria (5 listed)
- Adult patient above 30 years old.
- Clinically diagnosed osteoarthritis before treatment.
- Patient with refractory active osteoarthritis (not responding to treatment).
- Ability to sleep in fixed position for about 25 minutes
- Ability to provide informed consent.
Key exclusion criteria (5 listed)
- Patient with resolved osteoarthritis.
- patient with other disease in joints:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECT/CTCombined single photon emission computerized tomography and conventional computerized tomography (SPECT/CT) is a hybrid imaging modality, which combines a 3D bone scintigraphy (SPECT) and a conventional CT into one imaging procedure. The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional imaging (SPECT) | Device | – |
Primary outcome
Detecting different pattern of osseous MDP uptake in patient with osteoarthritis in hip joints and/or knees in relation to clinical and simple radiographic findings.
Time frame: Baseline
Osteoarthritic patients will be examined with 99mTc-methylene diphosphonate (MDP) bone SPECT, the sites of uptake will be localized. Simple radiograph and physical examination will be assessed.The relationships between clinical findings, simple radiographic findings and the intensity of uptake in SPECT will be analyzed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 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: status not confirmed, as of the sponsor's last update on 25 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma- Elzahraa Mostafa mahmoud (01095529911, fatma.mostafa07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detecting different pattern of osseous MDP uptake in patient with osteoarthritis in hip joints and/or knees in relation to clinical and simple radiographic findings. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.