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Completed

NCT Number: NCT04481230

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

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

CHU Clermont-Ferrand, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Drug

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

Drug

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

Primary outcomes

  1. 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).

  2. 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)

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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

  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

  6. 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

  7. 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

  8. 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.

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

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

Acronym: CARSPECT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2020
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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