Clinical trial NCT04481230: Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer
Official title: Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer: Phase I Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Osteoarthritis, Knee
Breast Cancer
Keywords: cartilage
proteoglycan tracer
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: dose escalation model
Primary purpose: DIAGNOSTIC

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 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.

Primary outcomes:
measure: determination of the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity
timeFrame: Imaging at Day 0 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours post-injection)
measure: dose-limiting toxicity (DLT)
timeFrame: 1 week after injection of the 99mTc-NTP 15-5 (Day 0)
Secondary outcomes:
measure: 3D quantification analysis
timeFrame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
measure: Safety of 99mTc-NTP 15-5 (frequence of adverse events)
timeFrame: 1 week after injection of the 99mTc-NTP 15-5 (Day 0)
measure: Biodistribution of 99mTc-NTP 15-5
timeFrame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
measure: Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Area Under the Curve (AUC)
timeFrame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
measure: Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Maximum Concentration (Cmax)
timeFrame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
measure: Pharmacokinetics of 99mTc-NTP 15-5 by assessment of the time take to reach Cmax (Tmax)
timeFrame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
measure: Urinary elimination of 99mTc-NTP 15-5
timeFrame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
measure: Dosimetry
timeFrame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: Centre Jean Perrin
name: Florent CACHIN, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thivat 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.