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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-12

Study Completion Date

2022-09-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis, Knee Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

dose escalation model

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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99mTc-NTP 15-5 (level 1)

99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg

Group Type EXPERIMENTAL

99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg

Intervention Type DRUG

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

99mTc-NTP 15-5 (level 2)

99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg

Group Type EXPERIMENTAL

99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg

Intervention Type DRUG

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

99mTc-NTP 15-5 (level 3)

99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg

Group Type EXPERIMENTAL

99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg

Intervention Type DRUG

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

Interventions

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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)

Intervention Type 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)

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- 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).

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No