- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03503825
[Tc-99m]-RPI-087 as an Imaging Marker in Osteoarthritis of the Knee Compared to Healthy Volunteers
A Phase 1, Open-label, Non-Randomized Study to Evaluate the Safety and Tolerability of [Tc-99m]-RPI T-087 Injection as an Imaging Marker for COX-2 in Subjects With Osteoarthritis of the Knee Compared to Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 1, non-randomized, open label, single centre clinical trial. 6 healthy volunteers (3 male and 3 female,4 study visits) and 6-18 subjects with Osteoarthritis of the knee (3 study visits) will be enrolled. At visit 2, all subjects will have knee pain assessed, using a visual analogue scale, prior to receiving a single, 555 MBq (15 mCi)+/-10% dose of [Tc-99m)-RPI-T-087 injection. Knees will be imaged with a SPECT/CT camera at specified time-points post injection. Safety monitoring will include vital signs, ECG, clinical laboratory tests (serum biochemistry, haematology, urinalysis) and adverse event monitoring.
Additionally, HVs will have whole body planar imaging and blood sampling conducted at Visit 2 and 3 to evaluate bio-distribution, estimate dosimetry and measure clearance of total activity over time in blood samples. A final follow-up visit will be conducted by phone interview.
Once 6 HVs and 6 KOA participants have completed the study, a blinded assessment of the image data will be conducted to determine whether any more KOA subjects should be imaged.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Janet Crouch, BScc, MRT(N)
- Phone Number: 35019 (905) 522-1155
- Email: jcrouch@stjoes.ca
Study Contact Backup
- Name: MaryLou Lawlor, RN
- Phone Number: 33790 (905) 522-1155
- Email: mlawlor@stjosham.on.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada
- Recruiting
- St. Joseph's Healthcare Hamilton
-
Contact:
- Janet Crouch, RTNM
- Phone Number: 35019 (905) 522-1155
-
Contact:
- MaryLou, RN
- Phone Number: 33790 (905) 522-1155
-
Principal Investigator:
- Karen Gulenchyn, MD
-
Sub-Investigator:
- Richard Adachi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria :
- All subjects must be able to read and speak in English and capable of giving signed informed consent.
- Female subjects must either, not be of reproductive potential, or not be pregnant and be willing to comply with appropriate family planning methods as specified in the protocol.
- Male subjects must either, not be of reproductive potential or be willing to comply with appropriate family planning methods as specified in the protocol.
Subjects with Knee Osteoarthritis (KOA)
- Age ≥ 40 to ≤ 70 years, at the time of signing the informed consent
- Have chronic pain due to OA of at least one knee identifiable as the target knee as their primary pain condition and some degree of pain every day from this condition.
For Healthy Volunteers:
- Age ≥ 18 to ≤ 35 years, at the time of signing the informed consent.
- No history of knee pain or known knee pathology confirmed by knee radiographs, obtained within the last year.
Exclusion Criteria:
- Chronic pain conditions other than OA of the knee (KOA) as their predominant pain condition
- Cannot or will not agree to stop: all topical, oral and parenteral non-steroidal anti-inflammatory drugs (NSAIDs) for at least 48 hours before administration of the IP; stop turmeric and curcumin (supplements and dietary sources) for at least 48 hours before administration of the IP; avoid all exercise from at least 24 hours before administration of the IP up to the end of the last applicable imaging session.
- Systemic (including inhaled) and oral corticosteroid use currently or within 6 weeks prior to Visit 1.
- Surgical interventions of either knee or any other major surgery within the previous 6 months.
- Receipt of intra-articular corticosteroid injections within the previous 6 weeks prior to Visit 1 in the target knee or within the previous 2 weeks prior to Visit 1 in any other joint.
- Use of any other investigational medication or devices within 30 days prior to Visit 1.
- Orthopedic or prosthetic appliance in either knee which may confound scan interpretation.
- Screening ECG or laboratory assessments showing clinically significant abnormalities
- Refusal or inability to tolerate the scanning procedures
- Allergies to or cannot tolerate NSAIDs, the investigational product or sulfa drugs
- History of bleeding disorders or history of documented gastrointestinal ulcer disease.
- Received significant ionizing radiation exposure, in the last 12 months or undergoing occupational monitoring for radiation exposure.
- Allergies or sensitivity to any component of the investigational product. Subjects taking disulfiram (Antabuse) should be excluded from this study.
- History of alcohol or substance abuse
- Any medical condition or disease that in the opinion of the investigator makes the subject unsuitable to participate in this study.
Study Plan
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: Healthy Volunteers
Healthy volunteers will be administered [Tc-99m]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety, knee image evaluation, and radioactivity biodistribution and dosimetry.
|
A single intravenous injection of [Tc-99m]-RPI-T-087 followed by SPECT/CT imaging of the knee (all subjects) and whole body planar imaging (Healthy volunteers only)
Other Names:
|
Experimental: Osteo Arthritis of the knee
Subjects with knee osteoarthritis will be administered [Tc-99m]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety and knee image evaluation.
|
A single intravenous injection of [Tc-99m]-RPI-T-087 followed by SPECT/CT imaging of the knee (all subjects) and whole body planar imaging (Healthy volunteers only)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment emergent adverse events
Time Frame: Up to 3 days post investigative product administration
|
The incidence of adverse events, including injection site reactions, clinically significant changes in clinical laboratory parameters (blood and urine), ECG's and vital signs, will be summarized over time to assess safety and tolerability.
|
Up to 3 days post investigative product administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Uptake over time
Time Frame: Up to 4.5 hours post administration of the investigational product
|
Quantitative standard uptake values (SUV) for T-087 will be determined for the knees of subjects with KOA and HVs, and comparing uptake in the target knee of OA subjects with the uptake in the knees of the HVs.
|
Up to 4.5 hours post administration of the investigational product
|
Image quality
Time Frame: Up to 4.5 hours post administration of the investigational product
|
A visual assessment using a scoring system will be used to assess the SPECT/CT images quality in subjects with KOA.
Image quality scales of 1 to 3, with 1 as unacceptable (non-interpretable quality), 2 as adequate quality for interpretation and 3 as excellent quality (no issues) of the target knee will be descriptively summarized by time point and subject group.
|
Up to 4.5 hours post administration of the investigational product
|
Dosimetry
Time Frame: Up to 1 day post administration of the investigational product.
|
Whole body planar imaging of healthy volunteers will be used to evaluate the biodistribution of [Tc-99m]-RPI-T-087 Injection to estimate dosimetry.
Whole body scintigraphic images will be quantified as to fractional activity (IA) in various visceral organs (e.g., liver, lungs, heart) as well as routes of excretion, total body and knees.
The data describing the uptake, retention and clearance in these tissues will characterize the biodistribution and biokinetics of the IP.
These data also serve as the foundation for radiation dose estimates for the IP.
|
Up to 1 day post administration of the investigational product.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clearance of [Tc-99m]-RPI-T-087
Time Frame: Up to 1 day post administration of the investigational product.
|
Blood sampling (HVs only) will support the exploratory objective of using radioactivity measurements (if measurable) to assess the clearance of [Tc-99m]-RPI-T-087.
|
Up to 1 day post administration of the investigational product.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karen Gulenchyn, MD, St. Joseph's Hospital Hamilton
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RPI-T-087-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on [Tc-99m]-RPI-T-087 Injection
-
Shanghai General Hospital, Shanghai Jiao Tong University...NanoMab Technology (UK) LimitedCompletedNon-Small Cell Lung CancerChina
-
Universitaire Ziekenhuizen KU LeuvenWithdrawn
-
Otsuka Pharmaceutical Co., Ltd.CovanceCompletedDyspeptic SubjectsUnited States
-
Navidea BiopharmaceuticalsNational Cancer Institute (NCI); National Institutes of Health (NIH)TerminatedLiver Metastases | Colorectal CarcinomaUnited States
-
University of ManitobaWinnipeg Regional Health AuthorityTerminated
-
Assistance Publique - Hôpitaux de ParisCompletedHealthy Subjects | Kleine-Levin SyndromeFrance
-
Dalian UniversityCompleted