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68Ga-labeled NY104 PET Imaging in Patients

Primary Purpose

Renal Cell Carcinoma

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NY104
Sponsored by
Affiliated Hospital of Jiangnan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; Exclusion Criteria: 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; 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.

Sites / Locations

  • Affiliated Hospital of Jiangnan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-NY104

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2022
Last Updated
November 27, 2022
Sponsor
Affiliated Hospital of Jiangnan University
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1. Study Identification

Unique Protocol Identification Number
NCT05638256
Brief Title
68Ga-labeled NY104 PET Imaging in Patients
Official Title
68Ga-labeled NY104 PET Imaging in Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Jiangnan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-NY104
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
68Ga-NY104
Intervention Description
Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY104
Primary Outcome Measure Information:
Title
Evaluation of tissue distribution of 68Ga-NY104
Description
Biodistribution of 68Ga-NY104 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunjing Yu
Phone
15312238622
Email
ycj_wxd1978@163.com
Facility Information:
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunjing Yu
Phone
15312238622
Email
ycj_wxd1978@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

68Ga-labeled NY104 PET Imaging in Patients

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