Clinical trial · Interventional
Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer
Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer: Phase I Clinical Trial
NCT04481230CI-TRIAL-00081199CARSPECTcompletedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Osteoarthritis, Knee | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg | Drug | — | UNRESOLVED |
| 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg | Drug | — | UNRESOLVED |
| 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 99mTc-NTP 15-5 (level 1)
- description
- 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
- interventionNames
- Drug: 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
- type
- EXPERIMENTAL
- label
- 99mTc-NTP 15-5 (level 2)
- description
- 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
- interventionNames
- Drug: 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
- type
- EXPERIMENTAL
- label
- 99mTc-NTP 15-5 (level 3)
- description
- 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 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 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.
References
Publications (2)
- DERIVEDChanchou M, Thivat E, Mathieu S, Levesque S, Sas N, Auzeloux P, Billoux T, Molnar I, Jouberton E, Rouanet J, Fois G, Maigne L, Penault-Llorca F, Miot-Noirault E, Durando X, Cachin F. [99mTc]Tc-NTP 15 - 5, a new proteoglycan tracer for functional imaging of joint cartilage: phase I (CARSPECT). EJNMMI Res. 2025 Sep 26;15(1):123. doi: 10.1186/s13550-025-01318-3. PMID 41003883
- DERIVEDThivat E, Chanchou M, Mathieu S, Levesque S, Billoux T, Auzeloux P, Sas N, Molnar I, Jouberton E, Rouanet J, Fois G, Maigne L, Galmier MJ, Penault-Llorca F, Miot-Noirault E, Durando X, Cachin F. Assessment of 99mTc-NTP 15-5 uptake on cartilage, a new proteoglycan tracer: Study protocol for a phase I trial (CARSPECT). Front Med (Lausanne). 2022 Oct 12;9:993151. doi: 10.3389/fmed.2022.993151. eCollection 2022. PMID 36314021