Back to resultsAssessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer (CARSPECT)
Primary Purpose
Osteoarthritis, Knee, Breast Cancer
Status
Completed
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteoarthritis, Knee focused on measuring cartilage, proteoglycan tracer
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.
Sites / Locations
- Centre Jean Perrin
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
99mTc-NTP 15-5 (level 1)
99mTc-NTP 15-5 (level 2)
99mTc-NTP 15-5 (level 3)
Arm Description
99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Outcomes
Primary Outcome Measures
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).
dose-limiting toxicity (DLT)
defined as any grade 3-4 toxicity according to the NCI-CTCAE (version 4.03)
Secondary Outcome Measures
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.
Safety of 99mTc-NTP 15-5 (frequence of adverse events)
according to the NCI-CTCAE (version 4.03)
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.
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Area Under the Curve (AUC)
radiation counting on whole blood and on plasma
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Maximum Concentration (Cmax)
radiation counting on whole blood and on plasma
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of the time take to reach Cmax (Tmax)
radiation counting on whole blood and on plasma
Urinary elimination of 99mTc-NTP 15-5
by counting
Dosimetry
measurement of the absorbed dose per organ will be evaluated by quantitative analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04481230
Brief Title
Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer
Acronym
CARSPECT
Official Title
Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer: Phase I Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
September 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Breast Cancer
Keywords
cartilage, proteoglycan tracer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
dose escalation model
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
99mTc-NTP 15-5 (level 1)
Arm Type
Experimental
Arm Description
99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
Arm Title
99mTc-NTP 15-5 (level 2)
Arm Type
Experimental
Arm Description
99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
Arm Title
99mTc-NTP 15-5 (level 3)
Arm Type
Experimental
Arm Description
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Intervention Type
Drug
Intervention Name(s)
99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
Intervention Description
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg (D0)
Intervention Type
Drug
Intervention Name(s)
99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
Intervention Description
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg (D0)
Intervention Type
Drug
Intervention Name(s)
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Intervention Description
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)
Primary Outcome Measure Information:
Title
determination of the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity
Description
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).
Time Frame
Imaging at Day 0 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours post-injection)
Title
dose-limiting toxicity (DLT)
Description
defined as any grade 3-4 toxicity according to the NCI-CTCAE (version 4.03)
Time Frame
1 week after injection of the 99mTc-NTP 15-5 (Day 0)
Secondary Outcome Measure Information:
Title
3D quantification analysis
Description
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.
Time Frame
imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
Title
Safety of 99mTc-NTP 15-5 (frequence of adverse events)
Description
according to the NCI-CTCAE (version 4.03)
Time Frame
1 week after injection of the 99mTc-NTP 15-5 (Day 0)
Title
Biodistribution of 99mTc-NTP 15-5
Description
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.
Time Frame
imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
Title
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Area Under the Curve (AUC)
Description
radiation counting on whole blood and on plasma
Time Frame
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Title
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Maximum Concentration (Cmax)
Description
radiation counting on whole blood and on plasma
Time Frame
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Title
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of the time take to reach Cmax (Tmax)
Description
radiation counting on whole blood and on plasma
Time Frame
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Title
Urinary elimination of 99mTc-NTP 15-5
Description
by counting
Time Frame
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Title
Dosimetry
Description
measurement of the absorbed dose per organ will be evaluated by quantitative analysis.
Time Frame
imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florent CACHIN, Pr
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
36314021
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.
Results Reference
derived
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Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer
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