Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer

• Status: Recruiting
• Trial end date: 2021-12-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Jean Perrin

Criteria

Inclusion Criteria:

Inclusion criteria specific to group 1:

• Patient with painful post-traumatic unilateral osteoarthritis of the knee as femorotibial pattern (except femoropatellar) 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 Criteria:

• 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.