68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC. (NYCRRT)

Effect of 68Ga-NY104 and 18F-FDG PET/CT Guided Radiation Therapy Combined with Systemic Treatment in Patients with Clear Cell Renal Cell Carcinoma.

Radiation therapy (RT) is an effective treatment for patients with advanced-stage clear cell renal cell carcinoma (ccRCC). Current evidence has shown promising outcomes combining radiation therapy and standard systemic therapy in patients with metastatic/recurrent ccRCC. CAIX is a highly sensitive and specific biomarker expressed on ccRCC and in previous studies the investigators have shown excellent diagnostic efficacy of 68Ga-NY104, a CAIX-targeted PET tracer, in patients with metastatic ccRCC. In this study, the investigators aim to investigate the effect of 68Ga-NY104, and 18F-FDG PET/CT guided RT combining standard systemic therapy in patients with metastatic ccRCC.

Study Overview

• Status: Recruiting
• Conditions: Clear Cell Renal Cell Carcinoma
• Intervention / Treatment: Drug: 68Ga-NY104 PET/CT; Drug: 18F-FDG PET/CT; Radiation: Radiation Therapy; Drug: Systemic therapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xianshu Gao, MD; Phone Number: +86 01083575641; Email: gao7777@139.com
• Study Contact Backup: Name: Mingwei Ma, MD; Phone Number: +86 0108372408; Email: dr.mingweima@stu.pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Xianshu Gao, MD; Phone Number: +86 01083575641; Email: gao7777@139.com
      • Contact: Mingwei Ma, MD; Phone Number: +86 0108372408; Email: dr.mingweima@stu.pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years old
• Histologically or cytologically confirmed clear cell renal cell carcinoma
• Eligible for radiation therapy: no more than 10 lesions in total
• Expected survival: over 3 months
• ECOG: 0 or 1
• Sufficient organ function
• Written informed consent

Exclusion Criteria:

• Brain metastasis/carcinomatous meningitis
• Other malignant tumors that are not controlled within 5 years, except for non-metastatic low-risk prostate cancer.
• Pregnant or breastfeeding.
• Active infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NY104 and FDG guided RT combining systemic therapy; In this arm, patients will undergo baseline evaluation using both 68Ga-NY104 and 18F-FGD PET/CT. Metastatic lesions will be identified based on these two PET/CTs and all other imaging modalities available. The radiation field will be planned to cover as much metastasis as possible if not all. Systemic therapy will be delivered at the same time. The patients will be followed up for disease status.

Drug: 68Ga-NY104 PET/CT; 68Ga-NY104 PET/CT will be performed at baseline, 6 months, 12 months, and 24 months after radiation therapy if the tumor is under control. If CT or MRI shows any suspicious recurrence or metastasis, 68Ga-NY104 PET/CT can be performed at the decision of the urology oncologist or radiation oncologist. The scan begins 1 hour after intravenous injection of 68Ga-NY104.; Drug: 18F-FDG PET/CT; 18F-FDG PET/CT will be performed at baseline and 6 months after radiation therapy. The scan begins 1 hour after intravenous injection of 18F-FDG.; Radiation: Radiation Therapy; Radiation therapy will be delivered to cover as much metastasis as possible if not all. For new lesions after radiation plus systemic therapy, if the new lesions are considered suitable for RT, RT can be delivered again without changing systemic therapy.; Drug: Systemic therapy; Systemic therapy will be delivered to patients to control the tumor. Possible regimen includes targeted therapy alone, immunotherapy alone, and targeted therapy combined with immunotherapy. The treatment regimen will be decided according to the urology oncologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival 2, PFS2	Progression Free Survival 2 (PFS2) was defined as the time from the beginning of treatment to the emergence of new lesions or the progression of original lesions, when the lesions could not be fully covered by radiotherapy, and the drug regimen had to be changed.	the time from the start of RT to 4 years after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion uptake on 68Ga-NY104 PET/CT		From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT
Lesion uptake on 18F-FDG PET/CT		From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT
Number of positive lesions detected on 68Ga-NY104 PET/CT		From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT
Number of positive lesions detected on 18F-FDG PET/CT		From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT
Number of lesions detected combining all available imaging modalities		From the start of any imaging modality to 1 week after completion of all imaging modalities
Objective response rate	The percentage of patients with complete remission or partial remission of tumor after treatment.	the time from the start of RT to 4 years after treatment
Progression free survival 1, PFS1	Progression Free Survival 1 (PFS1) was defined as the time from the beginning of treatment to the emergence of new lesions or the progression of original lesions.	the time from the start of RT to 4 years after treatment
Disease control rate	The percentage of patients with complete remission, partial remission, or stable disease after treatment.	the time from the start of RT to 4 years after treatment
Overall survival		the time from the start of RT to 4 years after treatment
Adverse event	The adverse event due to PET/CT and treatment will be recorded according to CTCAE 5.0.	the time from the start of RT to 4 years after treatment

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: radiation therapy; clear cell renal cell carcinoma; CAIX; 68Ga-NY104
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 2024-413-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No