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

Breast Cancer Clinical Trial

— CARSPECT  

Official title:

Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer: Phase I Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481230
• Other study ID #: 2020-000495-37
• Status: Completed
• Phase: Early Phase 1
• Start date: November 12, 2020
• Est. completion date: September 19, 2022

Study information

• Verified date: March 2023
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 19, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Osteoarthritis, Knee

Intervention

Drug:
• 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg (D0)
• 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg (D0)
• 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determination of the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity	defined as the dose from which 100% of patients will present a score 3 (semi-quantitative visual scale on whole body imaging) in at least 80% of healthy joints visualized on scintigraphies performed 2 h or less post-injection and without dose-limiting toxicity (DLT).	Imaging at Day 0 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours post-injection)
Primary	dose-limiting toxicity (DLT)	defined as any grade 3-4 toxicity according to the NCI-CTCAE (version 4.03)	1 week after injection of the 99mTc-NTP 15-5 (Day 0)
Secondary	3D quantification analysis	TEMP Volumetric regions of interest (VOI) will be centered on cartilaginous zones, and on the corresponding bony diaphyses or vertebral body or the adjacent muscles. The articular uptake of 99mTc NTP-15-5 will thus be normalized to bone or muscle uptake.	imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
Secondary	Safety of 99mTc-NTP 15-5 (frequence of adverse events)	according to the NCI-CTCAE (version 4.03)	1 week after injection of the 99mTc-NTP 15-5 (Day 0)
Secondary	Biodistribution of 99mTc-NTP 15-5	evaluated by measuring the percentage of injected activity of 99mTc-NTP 15-5 fixed on the target organs and on the pathological joints or healthy joints.	imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
Secondary	Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Area Under the Curve (AUC)	radiation counting on whole blood and on plasma	at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Secondary	Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Maximum Concentration (Cmax)	radiation counting on whole blood and on plasma	at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Secondary	Pharmacokinetics of 99mTc-NTP 15-5 by assessment of the time take to reach Cmax (Tmax)	radiation counting on whole blood and on plasma	at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Secondary	Urinary elimination of 99mTc-NTP 15-5	by counting	at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Secondary	Dosimetry	measurement of the absorbed dose per organ will be evaluated by quantitative analysis.	imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5