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.
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2024
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2024
CompletedFirst Submitted
Initial submission to the registry
September 23, 2024
CompletedFirst Posted
Study publicly available on registry
September 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
September 27, 2024
September 1, 2024
2.4 years
September 23, 2024
September 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (1)
NY104 and FDG guided RT combining systemic therapy
EXPERIMENTALIn 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.
Interventions
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.
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 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2024
First Posted
September 25, 2024
Study Start
March 27, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2028
Last Updated
September 27, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
all IPD that underlie results in a publication