Back to resultsA Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma
Primary Purpose
Clear Cell Renal Cell Carcinoma
Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NY104
Sponsored by
About this trial
This is an interventional diagnostic trial for Clear Cell Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria: Confirmed or suspected metastatic ccRCC Age ≥ 18 y Written informed consent provided for participation in the trial In the opinion of investigator, willing and able to comply with required study procedures. Exclusion Criteria: Patients on VEGF TKI treatment < 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required. Pregnancy or breastfeeding. Severe claustrophobia.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET scan
Arm Description
Patients will receive an intravenous injection of 68Ga-NY104
Outcomes
Primary Outcome Measures
Biodistribution of 68Ga-NY104 in normal organs
Uptake measured by SUVmax and SUVmean in normal organs using a region-of-interest technique
Tumor uptake of 68Ga-NY104
Uptake measured by SUVmax and SUVmean in suspected tumor lesions
Secondary Outcome Measures
Full Information
NCT ID
NCT05728515
First Posted
February 6, 2023
Last Updated
February 6, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05728515
Brief Title
A Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma
Official Title
Pilot Clinical Evaluation of a Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 25, 2021 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this pilot clinical trial is to see the potential application of a CAIX targeted PET. tracer in patients with clear cell renal cell carcinoma. The main question[s] it aims to answer are:
The biodistribution of the PET tracer
Whether RCC lesions can be identified by the PET tracer Participants will undergo 68Ga-NY104 PET/CT scan and images will be reviewed by nuclear medicine specialists.
Detailed Description
PET/CT imaging of three patients using 68Ga-NY104 for medical reasons will be performed. Patients received an intravenous injection of 68Ga-NY104. Images will be obtained at 0.5 h, 1 h, and 2 h after injection. A comparative 18F-FDG PET/CT scan will also be performed if necessary. The study will be carried out on a time-of-flight PET/CT scanner. SUVmax and SUVmean of normal organs and lesions, as well as tumor-to-background ratios, will be quantitatively assessed using a region-of-interest technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear Cell Renal Cell Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET scan
Arm Type
Experimental
Arm Description
Patients will receive an intravenous injection of 68Ga-NY104
Intervention Type
Drug
Intervention Name(s)
68Ga-NY104
Other Intervention Name(s)
no other intervention name
Intervention Description
Patients will undergo PET/CT scans after receiving an intravenous injection of 68Ga-NY104
Primary Outcome Measure Information:
Title
Biodistribution of 68Ga-NY104 in normal organs
Description
Uptake measured by SUVmax and SUVmean in normal organs using a region-of-interest technique
Time Frame
From study completion to 2 hour after completion
Title
Tumor uptake of 68Ga-NY104
Description
Uptake measured by SUVmax and SUVmean in suspected tumor lesions
Time Frame
From study completion to 2 hour after completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed or suspected metastatic ccRCC
Age ≥ 18 y
Written informed consent provided for participation in the trial
In the opinion of investigator, willing and able to comply with required study procedures.
Exclusion Criteria:
Patients on VEGF TKI treatment < 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
Pregnancy or breastfeeding.
Severe claustrophobia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Huo
Organizational Affiliation
Peking Uion Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Images and quantitative measures will be available upon on request
Learn more about this trial
A Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma
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