68Ga-NY104 PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

68Ga-NY104 PET/CT

About this trial

This is an interventional diagnostic trial for Metastatic Clear Cell Renal Cell Carcinoma focused on measuring 68Ga-NY104, PET/CT, Clear Cell Renal Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-NY104 PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

SUVmax of lesions detected by 68Ga-NY104 PET

The tracer uptake in focal lesions is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimentional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.

SUVmax of lesions detected by 18F-FDG PET

The tracer uptake in focal lesions is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimentional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.

Full Information

NCT ID

NCT05879471

First Posted

May 18, 2023

Last Updated

July 21, 2023

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05879471

Brief Title

68Ga-NY104 PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma

Official Title

68Ga-NY104 PET/CT and 18F-FDG PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma: a Prospective, Single Center, Single Arm, Comparative Imaging Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

July 1, 2025 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

Detailed Description

This is a prospective, single-center, single-arm, comparative phase 2 study in patients with metastatic clear cell renal cell carcinoma. Each patient will receive one dose of 68Ga-NY104 and one dose of 18F-FDG by intravenous route. Dedicated whole-body PET/CT imaging will be performed. PET/CT studies will be interpreted by two readers, both of whom will provide independent, blinded interpretations. Imaging interpretations and a composite reference standard will be used to estimate the sensitivity of each modality. The tumor uptake will also be compared for matched lesions. 39 patients will be recruited in Peking Union Medical College Hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Clear Cell Renal Cell Carcinoma

Keywords

68Ga-NY104, PET/CT, Clear Cell Renal Cell Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

68Ga-NY104 PET/CT

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

68Ga-NY104 PET/CT

Other Intervention Name(s)

68Ga-NYM005 PET/CT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Positivity of lesions detected by 68Ga-NY104 PET

Description

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

Time Frame

From study completion to 1 month after completion

Title

Positivity of lesions detected by 18F-FDG PET

Description

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

Time Frame

From study completion to 1 month after completion

Secondary Outcome Measure Information:

Title

SUVmax of lesions detected by 68Ga-NY104 PET

Description

The tracer uptake in focal lesions is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimentional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.

Time Frame

From study completion to 1 month after completion

Title

SUVmax of lesions detected by 18F-FDG PET

Description

The tracer uptake in focal lesions is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimentional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.

Time Frame

From study completion to 1 month after completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Huo, MD

Phone

18612672038

Email

huoli@pumch.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Wenjia Zhu, MD

Phone

18614080164

Email

zhuwenjia_pumc@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Huo, MD

Organizational Affiliation

Peking Uion Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenjia Zhu, MD

Email

zhuwenjia_pumc@163.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Available upon request

IPD Sharing Time Frame

Within 2 years after the publication of the main results

IPD Sharing Access Criteria

No limit.

Metastatic Clear Cell Renal Cell Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial