NCT05879471

Brief Summary

This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. The goal is to determine the sensitivity of 68Ga-NY104 PET/CT in patients with metastatic clear cell renal cell carcinoma and compare it with 18F-FDG PET/CT.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

May 18, 2023

Last Update Submit

July 21, 2023

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Keywords

68Ga-NY104PET/CTClear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Positivity of lesions detected by 68Ga-NY104 PET

    Any focal accumulation that cannot be explained by physiologic uptake of the 68Ga-NY104 will be interpreted as focal lesion.

    From study completion to 1 month after completion

  • Positivity of lesions detected by 18F-FDG PET

    Any focal accumulation that cannot be explained by physiologic uptake of 18F-FDG will be interpreted as focal lesion.

    From study completion to 1 month after completion

Secondary Outcomes (2)

  • SUVmax of lesions detected by 68Ga-NY104 PET

    From study completion to 1 month after completion

  • SUVmax of lesions detected by 18F-FDG PET

    From study completion to 1 month after completion

Study Arms (1)

68Ga-NY104 PET/CT

EXPERIMENTAL

Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.

Diagnostic Test: 68Ga-NY104 PET/CT

Interventions

68Ga-NY104 PET/CTDIAGNOSTIC_TEST

Participants will be administered a single, intravenous bolus of 68Ga-NY104 The recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NY104 administration.

Also known as: 68Ga-NYM005 PET/CT
68Ga-NY104 PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 y
  • Histopathological diagnosis of clear cell renal cell carcinoma
  • Metastatic disease confirmed by histopathology or typical appearance of multifocal metastatic disease
  • Expected survival of at least 6 months
  • ECOG ≤ 2
  • Written informed consent provided for participation in the trial
  • In the opinion of investigator, willing and able to comply with required study procedures.

You may not qualify if:

  • On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY104. 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.
  • Patients on HIF antagonist treatment \< 3 months before 68Ga-NY104 PET/CT. CA9, which encodes carbonic anhydrase IX (CAIX), is one of the genes most strongly upregulated by HIF-1. HIF antagonist, such as Belzutifan, might affect the expression of CAIX and thus the binding of 68Ga-NY104 to tumor. Withdraw of at least 3 months is required for HIF antagonist.
  • Pregnancy or breastfeeding.
  • Severe claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinomaCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Li Huo, MD

    Peking Uion Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Huo, MD

CONTACT

18612672038huoli@pumch.cn

Wenjia Zhu, MD

CONTACT

18614080164zhuwenjia_pumc@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 30, 2023

Study Start

August 1, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Available upon request

Shared Documents
STUDY PROTOCOL
Time Frame
Within 2 years after the publication of the main results
Access Criteria
No limit.

Locations

CN(1)