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Trial Title:
Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM005 in Patients
NCT ID:
NCT06389682
Condition:
Clear Cell Renal Cell Carcinoma Metastatic
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-NYM005 injection
Description:
he radiation dose is about 2-7 mCi for a single patient.Using a syringe to withdraw
68Ga-NYM005 injection, the dose will be administered via an intravenous injection and the
injection time will be about 45-60 seconds.
Arm group label:
68Ga-NYM005 injection
Summary:
68Ga-NYM005 is a CAIX-targeting small-molecular radiotracer for PET/CT imaging of clear
cell renal cell carcinoma
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with pathologically confirmed metastatic renal clear cell carcinoma;
2. Age range from 18 to 75 years old (including 18 and 75 years old);
3. ECOG score of 0 or 1;
4. Expected life > 6 months;
5. GFR> 60 ml/min;
6. Women of childbearing age need to have a negative pregnancy test, and the
subjects(including male subjects)agree to take effective contraceptive measures
during the study period and for at least three months after the drug administration;
7. The subjects are able to maintain good communication with the researchers；understand
and follow the requirements of this study and sign an informed consent form before
the start of relevant research operations.
Exclusion Criteria:
1. Pregnant or lactating women, or women who plan to conceive during the study period
or within three months after drug administration;
2. Known or suspected to be allergic to the investigational drug or any of its
components,acetazolamide or other sulfonamides:
3. Accepting other investigational drugs upon enrollment, or within 5 biological
half-lives of the drug at enrollment, or within 30 days after its last
administration, whichever is longer;
4. Those who have used any radioactive therapy medication within 90 days before
investigational drug administration, or have received any radioactive diagnostic
medication within 3 days before investigational drug administration;
5. On VEGF TKI treatment less than 7 days before 68Ga-NYM005 PET/CT, such as
sunitinib,sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week
before 68Ga-NYM005 PET/CT is required;
6. Planned (for the period between injection of 68Ga-NYM005 and imaging) antineoplastic
therapies;
7. Plan to arrange surgery and other invasive interventions within 2 days after the
injection of the investigational drug;
8. Ongoing toxicity >grade l from previous standard or investigational therapies；
9. Patients with active infections during screening;
10. Those who have no guarantee of being able to lie down quietly in the examination
cabin during a PET examination, or those who suffer from claustrophobia and cannot
cooperate in a PET examination:
11. Other situations where the researchers believe that the subject is not suitable for
inclusion in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affliated Hospital of Jiangnan University
Address:
City:
Wuxi
Zip:
214000
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunjing Yu
Phone:
15312238622
Email:
ycj_wxd1978@163.com
Start date:
May 2024
Completion date:
December 2024
Lead sponsor:
Agency:
Norroy Bioscience Co., LTD
Agency class:
Industry
Source:
Norroy Bioscience Co., LTD
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06389682
