Renal Cell CarcinomaEarly Phase 1NCT05638256
68Ga-labeled NY104 PET Imaging in Patients
A Early Phase 1 study testing 68Ga-NY104 in people with Renal Cell Carcinoma, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY104 PET Imaging in patients with Renal Cell Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- 68Ga-NY104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2022to Oct 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily signed informed consent;
- Age 18-75, male or female;
- Patients diagnosed with renal cell carcinoma confirmed by histopathology or cytology;
- At least one measurable solid lesion has been examined according RECIST1.1 standard;
- ECOG score 0~3; Life expectancy of at least 3 months;
Who cannot join
- Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
- Patients with systemic or locally severe infections, or other serious coexisting diseases;
- Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
- Patients with autoimmune diseases, including rheumatoid arthritis;
- Inadequate control of arrhythmias, including atrial fibrillation;
- Uncontrolled hypertension;
Show all 13Show fewer
- Patients with allergies or allergies to any component of the imaging agent or antibody;
- Patients who cannot undergo PET/CT imaging scan;
- Syphilis, HBV, HCV, or HIV positive subjects;
- Male and female subjects of reproductive age cannot take effective contraceptive measures;
- Pregnant or lactating women;
- Patients with a history of mental illness or related conditions;
- Other subjects considered unsuitable by researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000
Chunjing Yu, 15312238622, ycj_wxd1978@163.com
About this study
This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY104 PET Imaging in patients with Renal Cell Carcinoma
- Conditions
- Renal Cell Carcinoma
- Being tested
- 68Ga-NY104
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NY104Drug
Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY104
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NY104 | Experimental | Not described Receives: Drug: 68Ga-NY104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of tissue distribution of 68Ga-NY104
Biodistribution of 68Ga-NY104 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start10 Oct 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjing Yu, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638256
- Sponsor's protocol ID
- LS2020003
- Status last verified
- Nov 2022
- First submitted
- 27 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lou K, Wang J, He H, Wang Y, Mi Y, Li W, Chen L, Zhang Y, Mao Y, Lin J, Fu H, Yu C. Value of [68Ga]Ga-NYM046 PET/CT, in Comparison with 18F-FDG PET/CT, for Diagnosis of Clear Cell Renal Cell Carcinoma. J Nucl Med. 2024 Dec 3;65(12):1884-1890. doi: 10.2967/jnumed.124.267527.
PubMed 39542699
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-labeled NY104 PET Imaging in Patients
- ClinicalTrials.gov ID
- NCT05638256
- Acronym / sponsor ID
- LS2020003
- Conditions
- Renal Cell Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY104 PET Imaging in patients with Renal Cell Carcinoma
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NY104 | Experimental | Drug: 68Ga-NY104 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients voluntarily signed informed consent;
- Age 18-75, male or female;
- Patients diagnosed with renal cell carcinoma confirmed by histopathology or cytology;
- At least one measurable solid lesion has been examined according RECIST1.1 standard;
- ECOG score 0~3; Life expectancy of at least 3 months;
Key exclusion criteria (13 listed)
- Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
- Patients with systemic or locally severe infections, or other serious coexisting diseases;
- Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
- Patients with autoimmune diseases, including rheumatoid arthritis;
- Inadequate control of arrhythmias, including atrial fibrillation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NY104Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY104 | Drug | 68Ga-NY104 |
Primary outcome
Evaluation of tissue distribution of 68Ga-NY104
Time frame: 1 year
Biodistribution of 68Ga-NY104 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Derived from this study: PubMed 39542699Lou K, Wang J, He H, Wang Y, Mi Y, Li W, Chen L, Zhang Y, Mao Y, Lin J, Fu H, Yu C. Value of [68Ga]Ga-NYM046 PET/CT, in Comparison with 18F-FDG PET/CT, for Diagnosis of Clear Cell Renal Cell Carcinoma. J Nucl Med. 2024 Dec 3;65(12):1884-1890. doi: 10.2967/jnumed.124.267527.
- Individual participant dataSharing planned: No
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-NY104 in people with Renal Cell Carcinoma, run by Affiliated Hospital of Jiangnan University at 1 site in China.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunjing Yu (15312238622, ycj_wxd1978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of tissue distribution of 68Ga-NY104 (time frame: 1 year). 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 NCT05638256, which also lists 1 linked publication.
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 6 Dec 2022.