NCT05902377

Brief Summary

This is a prospective, single-center study in patients with renal cell carcinoma. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma.

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
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2021

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

Study Start

First participant enrolled

December 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

June 5, 2023

Last Update Submit

June 5, 2023

Conditions

Renal Cell Carcinoma

Keywords

68Ga-NY104carbonic anhydrase IX

Outcome Measures

Primary Outcomes (1)

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

    Define lesion as PET positive or PET negative lesion.

    From study completion to 1 month after completion

Secondary Outcomes (1)

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

    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:

  • Written informed consent provided for participation in the trial
  • Age ≥ 18 y
  • at least one of the following indications should be applied
  • Scheduled for surgical resection of renal mass
  • confirmed recurrent/metastatic clear cell renal cell carcinoma
  • suspicion for recurrent/metastatic clear cell renal cell carcinoma

You may not qualify if:

  • On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT.
  • Pregnancy or lactation
  • 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

Related Publications (1)

  • Zhu W, Zheng G, Yan X, Liu M, Li X, Cheng Y, Bai C, Zhang Y, Huo L. Diagnostic efficacy of [68Ga]Ga-NY104 PET/CT to identify clear cell renal cell carcinoma. Eur J Nucl Med Mol Imaging. 2024 Nov;51(13):4127-4133. doi: 10.1007/s00259-024-06801-y. Epub 2024 Jun 25.

    PMID: 38916753DERIVED

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

  • Huo Li, MD

    Peking Uion Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huo Li, 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

June 5, 2023

First Posted

June 15, 2023

Study Start

December 1, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)