Status:
COMPLETED
Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer
Lead Sponsor:
Centre Jean Perrin
Conditions:
Osteoarthritis, Knee
Breast Cancer
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
This study is a phase I clinical trial aimed to determine the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity.
Eligibility Criteria
Inclusion
- Inclusion criteria specific to group 1:
- \- Patient with painful unilateral osteoarthritis of the knee as femorotibial pattern defined by a radiographic score of 0/1 from Kellgren / Lawrence and an average WOMAC score\> or equal to 4 and by minor disorders at MRI (MOCART 2.0 score\> 70).
- Inclusion criteria specific to group 2:
- Patient with non-metastatic breast cancer, hormone receptor positive, HER2 negative, with indication for adjuvant therapy with aromatase inhibitor; treatment not yet started.
- Age \<60 years
- Common inclusion criteria:
- Patient with at least 31 healthy joints (based on clinical assessment)
- signed written informed consent.
- Affiliation to a health insurance scheme.
- For women of childbearing age : negative serum pregnancy test at inclusion (less than 7 days prior injection of 99mTc-NTP 15-5).
- Willing and able to comply with study visits, treatment, exams and the protocol.
Exclusion
- Patients \<18 years of age.
- Pregnant or lactating patient.
- BMI\> 30
- History of known allergy to excipients contained in the solution of 99mTc-NTP 15-5
- Chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthropathy, psoriatic arthritis, etc.) diffuse arthritis (at least 3 joints affected), autoimmune connectivitis, fibromyalgia.
- Known chronic joint pathology: osteoarthritis affecting at least 3 joints, autoimmune disease, inflammatory rheumatism (except unilateral knee arthritis).
- Persons deprived of their liberty, under guardianship / curatorship, or safeguard of justice.
- Treatment with NSAIDs or cessation of less than 48 h.
- Inability to comply with medical requirement / follow-up of the trial for geographic, family, social or psychological reasons. These conditions should be discussed with the patient before registration in the study.
Key Trial Info
Start Date :
November 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04481230
Start Date
November 12 2020
End Date
September 19 2022
Last Update
October 1 2024
Active Locations (2)
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1
Centre Jean Perrin
Clermont-Ferrand, France, 63011
2
CHU Clermont-Ferrand
Clermont-Ferrand, France