68Ga-NY104 PET/CT Imaging in Renal Cell Carcinoma

NCT ID: NCT05902377

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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Two types of patients will be recruited in this study. Type 1, patients with renal masses scheduled for surgery, type 2, patients with confirmed or suspicious recurrent/metastatic ccRCC. Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Imaging interpretations and reference standards will be used to estimate the sensitivity and specificity of 68G-NY104 PET/CT.

46 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.

Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-NY104 PET/CT

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

Group Type EXPERIMENTAL

68Ga-NY104 PET/CT

Intervention Type DIAGNOSTIC_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.

Interventions

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68Ga-NY104 PET/CT

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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68Ga-NYM005 PET/CT

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent provided for participation in the trial
2. Age ≥ 18 y
3. at least one of the following indications should be applied

1. Scheduled for surgical resection of renal mass
2. confirmed recurrent/metastatic clear cell renal cell carcinoma
3. suspicion for recurrent/metastatic clear cell renal cell carcinoma

Exclusion Criteria

1. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT.
2. Pregnancy or lactation
3. Severe claustrophobia.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huo Li, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Uion Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huo Li, MD

Role: CONTACT

18612672038

Wenjia Zhu, MD

Role: CONTACT

18614080164

Facility Contacts

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Wenjia Zhu

Role: primary

18614080164

References

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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.

Reference Type DERIVED
PMID: 38916753 (View on PubMed)

Other Identifiers

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NYCR

Identifier Type: -

Identifier Source: org_study_id

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