Overview

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.