NCT05879510

Brief Summary

This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground truth, in patients with operable renal masses.

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
63

participants targeted

Target at P50-P75 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 13, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

May 18, 2023

Last Update Submit

July 11, 2023

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

68Ga-NY104PET/CTrenal mass

Outcome Measures

Primary Outcomes (2)

  • Binary reading of renal lesions identified on 68Ga-NY104 PET/CT

    Define lesion as PET positive or PET negative lesion. The kidney lesion is designated as positive if the SUVmax of kidney lesions is higher than that of liver (reference).

    From study completion to 1 month after completion

  • Histological classification of operated renal lesions

    The histological classification of operated renal lesions will be determined according to WHO classification of tumors, Feb 2004.

    From study completion to 1 month after completion

Secondary Outcomes (13)

  • SUVmax of renal lesions identified on 68Ga-NY104 PET/CT

    From study completion to 1 month after completion

  • SUVmax of liver uptake on 68Ga-NY104 PET/CT

    From study completion to 1 month after completion

  • Tumor grade of operated renal lesions

    From study completion to 1 month after completion

  • Intensity of CAIX staining of operated renal lesions

    From study completion to 1 month after completion

  • Extent of CAIX staining of operated renal lesions

    From study completion to 1 month after completion

  • +8 more secondary outcomes

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
  • Presence of a renal mass
  • Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
  • Expected survival of at least 3 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.
  • Intercurrent medical condition that renders the patient ineligible for surgery.
  • 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

Carcinoma, 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 13, 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)