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Osteoarthritis, KneeEarly Phase 1CARSPECTNCT04481230

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

A Early Phase 1 study testing 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg, 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg and 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg in people with Osteoarthritis, Knee and Breast Cancer, run by Centre Jean Perrin at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Osteoarthritis, Knee, Breast Cancer
What is being tested?
99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg, 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg and 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesFrance
Study dates
12 Nov 2020to 19 Sep 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
  • Common inclusion criteria:
  • Patient with at least 31 healthy joints (based on clinical assessment)
  • signed written informed consent.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • CHU Clermont-Ferrand

    Clermont-Ferrand

Other trials in France

About this study

Official title: 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.

Being tested
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
Keywords
cartilage, proteoglycan tracer
Medical subject headings
Osteoarthritis, Knee, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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 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)

Study groups in NCT04481230
Study groupRoleWhat they receive
99mTc-NTP 15-5 (level 1)Experimental99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
Receives: Drug: 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg
99mTc-NTP 15-5 (level 2)Experimental99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
Receives: Drug: 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg
99mTc-NTP 15-5 (level 3)Experimental99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Receives: Drug: 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. dose-limiting toxicity (DLT)

    defined as any grade 3-4 toxicity according to the NCI-CTCAE (version 4.03)

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

Secondary outcomes (8)

  1. 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.

    Measured: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5

  2. Safety of 99mTc-NTP 15-5 (frequence of adverse events)

    according to the NCI-CTCAE (version 4.03)

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

  3. 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.

    Measured: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5

  4. Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Area Under the Curve (AUC)

    radiation counting on whole blood and on plasma

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

  5. Pharmacokinetics of 99mTc-NTP 15-5 by assessment of Maximum Concentration (Cmax)

    radiation counting on whole blood and on plasma

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

  6. Pharmacokinetics of 99mTc-NTP 15-5 by assessment of the time take to reach Cmax (Tmax)

    radiation counting on whole blood and on plasma

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

  7. Urinary elimination of 99mTc-NTP 15-5

    by counting

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

  8. Dosimetry

    measurement of the absorbed dose per organ will be evaluated by quantitative analysis.

    Measured: imaging at Day 0, 30 minutes, 2 hours, 4 hours, 6-8 hours after injection of the 99mTc-NTP 15-5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2020
  2. Study start12 Nov 2020
  3. Primary completion28 Jul 2022
  4. Study completion19 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
dose escalation model
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04481230
Sponsor's protocol ID
2020-000495-37
Acronym
CARSPECT
Status last verified
Sep 2023
First submitted
2 Jul 2020
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41003883

  • 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.

    PubMed 36314021

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg, 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg and 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg in people with Osteoarthritis, Knee and Breast Cancer, run by Centre Jean Perrin at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04481230, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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