NCT04481230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 12, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2022

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

July 2, 2020

Last Update Submit

September 30, 2024

Conditions

Osteoarthritis, KneeBreast Cancer

Keywords

cartilageproteoglycan tracer

Outcome Measures

Primary Outcomes (2)

  • 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).

    Imaging at Day 0 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours post-injection)

  • dose-limiting toxicity (DLT)

    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 Outcomes (8)

  • 3D quantification analysis

    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)

    1 week after injection of the 99mTc-NTP 15-5 (Day 0)

  • Biodistribution of 99mTc-NTP 15-5

    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)

    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)

    at Day 0 during the first 8 hours after injection of the 99mTc-NTP 15-5

  • +3 more secondary outcomes

Study Arms (3)

99mTc-NTP 15-5 (level 1)

EXPERIMENTAL

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

99mTc-NTP 15-5 (level 2)

EXPERIMENTAL

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

99mTc-NTP 15-5 (level 3)

EXPERIMENTAL

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

Interventions

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

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

99mTc-NTP 15-5 (level 1)
99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kgDRUG

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

99mTc-NTP 15-5 (level 2)
99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kgDRUG

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

99mTc-NTP 15-5 (level 3)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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.
  • Willing and able to comply with study visits, treatment, exams and the protocol.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Related Publications (2)

  • Chanchou M, Thivat E, Mathieu S, Levesque S, Sas N, Auzeloux P, Billoux T, Molnar I, Jouberton E, Rouanet J, Fois G, Maigne L, Penault-Llorca F, Miot-Noirault E, Durando X, Cachin F. [99mTc]Tc-NTP 15 - 5, a new proteoglycan tracer for functional imaging of joint cartilage: phase I (CARSPECT). EJNMMI Res. 2025 Sep 26;15(1):123. doi: 10.1186/s13550-025-01318-3.

    PMID: 41003883DERIVED

  • 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.

    PMID: 36314021DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeBreast Neoplasms

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Florent CACHIN, Pr

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: dose escalation model
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 22, 2020

Study Start

November 12, 2020

Primary Completion

July 28, 2022

Study Completion

September 19, 2022

Last Updated

October 1, 2024

Record last verified: 2023-09

Locations

FR(2)