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A Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05728515
Collaborator
(none)
3
Enrollment
1
Location
1
Arm
2.3
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pilot Clinical Evaluation of a Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma
Actual Study Start Date :
Dec 25, 2021
Actual Primary Completion Date :
Mar 4, 2022
Actual Study Completion Date :
Mar 4, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: PET scan

Patients will receive an intravenous injection of 68Ga-NY104

Drug: 68Ga-NY104
Patients will undergo PET/CT scans after receiving an intravenous injection of 68Ga-NY104
Other Names:
  • no other intervention name

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Biodistribution of 68Ga-NY104 in normal organs [From study completion to 2 hour after completion]

      Uptake measured by SUVmax and SUVmean in normal organs using a region-of-interest technique

    2. Tumor uptake of 68Ga-NY104 [From study completion to 2 hour after completion]

      Uptake measured by SUVmax and SUVmean in suspected tumor lesions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Confirmed or suspected metastatic ccRCC

    2. Age ≥ 18 y

    3. Written informed consent provided for participation in the trial

    4. In the opinion of investigator, willing and able to comply with required study procedures.

    Exclusion Criteria:

    1. 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.

    2. Pregnancy or breastfeeding.

    3. Severe claustrophobia.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Principal Investigator: Li Huo, Peking Uion Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05728515
    Other Study ID Numbers:
    • NYPILOT
    First Posted:
    Feb 15, 2023
    Last Update Posted:
    Feb 15, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of Feb 15, 2023