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

March 6, 2023 updated by: Centre Jean Perrin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 99mTc-NTP 15-5 (level 1)
99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
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)
Experimental: 99mTc-NTP 15-5 (level 2)
99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
Drug: 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)
Experimental: 99mTc-NTP 15-5 (level 3)
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determination of the recommended dose of 99mTc-NTP 15-5 to obtain the best tracer joints contrast on images without any toxicity
Time Frame: Imaging at Day 0 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours post-injection)
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)
dose-limiting toxicity (DLT)
Time Frame: 1 week after injection of the 99mTc-NTP 15-5 (Day 0)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D quantification analysis
Time Frame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
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
Safety of 99mTc-NTP 15-5 (frequence of adverse events)
Time Frame: 1 week after injection of the 99mTc-NTP 15-5 (Day 0)
according to the NCI-CTCAE (version 4.03)
1 week after injection of the 99mTc-NTP 15-5 (Day 0)
Biodistribution of 99mTc-NTP 15-5
Time Frame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 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
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Area Under the Curve (AUC)
Time Frame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
radiation counting on whole blood and on plasma
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Maximum Concentration (Cmax)
Time Frame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
radiation counting on whole blood and on plasma
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Pharmacokinetics of 99mTc-NTP 15-5 by assessment of the time take to reach Cmax (Tmax)
Time Frame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
radiation counting on whole blood and on plasma
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Urinary elimination of 99mTc-NTP 15-5
Time Frame: at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
by counting
at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5
Dosimetry
Time Frame: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2020

Primary Completion (Actual)

July 28, 2022

Study Completion (Actual)

September 19, 2022

Study Registration Dates

First Submitted

July 2, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-000495-37

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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