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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04481230




Registration number
NCT04481230
Ethics application status
Date submitted
2/07/2020
Date registered
22/07/2020
Date last updated
1/10/2024

Titles & IDs
Public title
Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer
Scientific title
Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer: Phase I Clinical Trial
Secondary ID [1] 0 0
2020-000495-37
Universal Trial Number (UTN)
Trial acronym
CARSPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Breast Cancer 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
Treatment: Drugs - 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
Treatment: Drugs - 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg

Experimental: 99mTc-NTP 15-5 (level 1) - 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg

Experimental: 99mTc-NTP 15-5 (level 2) - 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg

Experimental: 99mTc-NTP 15-5 (level 3) - 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg


Treatment: Drugs: 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)

Treatment: Drugs: 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)

Treatment: Drugs: 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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
determination of the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity
Timepoint [1] 0 0
Imaging at Day 0 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours post-injection)
Primary outcome [2] 0 0
dose-limiting toxicity (DLT)
Timepoint [2] 0 0
1 week after injection of the 99mTc-NTP 15-5 (Day 0)
Secondary outcome [1] 0 0
3D quantification analysis
Timepoint [1] 0 0
imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
Secondary outcome [2] 0 0
Safety of 99mTc-NTP 15-5 (frequence of adverse events)
Timepoint [2] 0 0
1 week after injection of the 99mTc-NTP 15-5 (Day 0)
Secondary outcome [3] 0 0
Biodistribution of 99mTc-NTP 15-5
Timepoint [3] 0 0
imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
Secondary outcome [4] 0 0
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Area Under the Curve (AUC)
Timepoint [4] 0 0
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Secondary outcome [5] 0 0
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Maximum Concentration (Cmax)
Timepoint [5] 0 0
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Secondary outcome [6] 0 0
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of the time take to reach Cmax (Tmax)
Timepoint [6] 0 0
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Secondary outcome [7] 0 0
Urinary elimination of 99mTc-NTP 15-5
Timepoint [7] 0 0
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Secondary outcome [8] 0 0
Dosimetry
Timepoint [8] 0 0
imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/09/2022
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Clermont-Ferrand

Funding & Sponsors
Primary sponsor type
Other
Name
Centre Jean Perrin
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Florent CACHIN, Pr
Address 0 0
Centre Jean Perrin
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04481230