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Trial Title:
68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC.
NCT ID:
NCT06613269
Condition:
Clear Cell Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Fluorodeoxyglucose F18
Conditions: Keywords:
clear cell renal cell carcinoma
CAIX
radiation therapy
68Ga-NY104
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-NY104 PET/CT
Description:
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.
Arm group label:
NY104 and FDG guided RT combining systemic therapy
Intervention type:
Drug
Intervention name:
18F-FDG PET/CT
Description:
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.
Arm group label:
NY104 and FDG guided RT combining systemic therapy
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
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.
Arm group label:
NY104 and FDG guided RT combining systemic therapy
Intervention type:
Drug
Intervention name:
Systemic therapy
Description:
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.
Arm group label:
NY104 and FDG guided RT combining systemic therapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianshu Gao, MD
Phone:
+86 01083575641
Email:
gao7777@139.com
Contact backup:
Last name:
Mingwei Ma, MD
Phone:
+86 0108372408
Email:
dr.mingweima@stu.pku.edu.cn
Start date:
March 27, 2024
Completion date:
September 2028
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University First Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06613269
