Diagnosis of Renal Cell Carcinoma on 68Ga-PSMA PET-CT and Radioligand Therapy With 177Lu-EB-PSMA-617
Primary Purpose
Renal Cell Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga-PSMA
1.85GBq (50 mCi) of 177Lu-EB-PSMA-617
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- confirmed treated or untreated renal cell carcinoma patients;
- 68Ga-PSMA PET/CT and 18F-FDG PET/CT within two weeks;
- signed written consent.
Exclusion Criteria:
- pregnancy;
- breastfeeding;
- known allergy against PSMA
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-PSMA, PET/CT and 177Lu-EB- PSMA-617 therapy
Arm Description
All patients diagnosed with RCC underwent 68Ga-PSMA PET/CT scan. If the PET/CT showed high PSMA expression in tumor lesions of some patients, they would intravenously injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 for therapy.
Outcomes
Primary Outcome Measures
Diagnostic value
Sensitivity and Specificity of 68Ga-PSMA PET/CT for Renal Cell Carcinoma in comparison with 18F-FDG PET/CT
Secondary Outcome Measures
Safety of therapy
the safety assessed by CTCAE v4.0
Full Information
NCT ID
NCT05170555
First Posted
December 24, 2021
Last Updated
December 24, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05170555
Brief Title
Diagnosis of Renal Cell Carcinoma on 68Ga-PSMA PET-CT and Radioligand Therapy With 177Lu-EB-PSMA-617
Official Title
Diagnosis of Renal Cell Carcinoma on 68Ga-PSMA PET-CT and Radioligand Therapy With 177Lu-EB-PSMA-617
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
July 1, 2023 (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
5. Study Description
Brief Summary
Renal Cell Carcinoma (RCC) is the second most common tumor in urology. Considering its origination from kidney, an organ with intense physiological uptake and excretion of 68Ga-PSMA, this study aims to evaluate the uptake of 68Ga-PSMA in RCC compared to 18F-FDG in the same patients, and assess the feasibility of 177Lu-EB-PSMA-617 treatment in patients with the advanced RCC.
Detailed Description
Renal Cell Carcinoma (RCC) is the second most common tumor in urology. As one of the popular urinary tumors, the incidence rate increases by 2-4% per year. Localized RCC is generally cured by surgery, which has achieved good efficacy. However, advanced RCC are still the main factors influencing the survival of RCC patients due to its intrinsic resistance to conventional chemotherapy or radiotherapy. 18F-FDG PET/CT is considered to be a viable tool to assess RCC at initial presentation. However, FDG uptake in RCC is lower than most other solid tumors and is indistinguishable from benign lesions. So, it is necessary to find another effective way to detect RCC and its metastases. As in known, pro-angiogenic factors (VEGF, PDGF) are strongly upregulated in clear cell RCC, leading to high vascularized tumors. 68Ga-PSMA has been developed as a targeting imaging agent widely used in prostate cancer in prostate cancer. Thus, this prospective study is going to investigate whether 68Ga-PSMA PET/CT may be superior for diagnosis, therapy response assessment and follow-up of RCC than 18F-FDG PET/CT. Furthermore, peptide receptor radionuclide therapy has been widely used in the treatment of prostate cancer lesions that showed high PSMA uptake on 68Ga-PSMA PET/CT, we'll try to assess the safety and therapeutic response to 177Lu-EB-PSMA-617 in patients with RCC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-PSMA, PET/CT and 177Lu-EB- PSMA-617 therapy
Arm Type
Experimental
Arm Description
All patients diagnosed with RCC underwent 68Ga-PSMA PET/CT scan. If the PET/CT showed high PSMA expression in tumor lesions of some patients, they would intravenously injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 for therapy.
Intervention Type
Drug
Intervention Name(s)
68Ga-PSMA
Intervention Description
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-PSMA. Tracer doses of 68Ga- PSMA will be used to image lesions of Renal Cell Carcinoma by PET/CT.
Intervention Type
Drug
Intervention Name(s)
1.85GBq (50 mCi) of 177Lu-EB-PSMA-617
Intervention Description
Patients were intravenous injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
Primary Outcome Measure Information:
Title
Diagnostic value
Description
Sensitivity and Specificity of 68Ga-PSMA PET/CT for Renal Cell Carcinoma in comparison with 18F-FDG PET/CT
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Safety of therapy
Description
the safety assessed by CTCAE v4.0
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Therapeutic effect
Description
the therapeutic response assessed by PSMA PET/CT to 177Lu-EB-PSMA-617 in patients with Renal Cell Carcinoma.
Time Frame
through study completion, an average of 1 year
Title
Correlation between PSMA expression and SUV in PET/CT
Description
to mearsure the SUVmax of RCC on PSMA PET/CT and to investigate the expression of PSMA on primary, recurrent and metastatic RCC tumour tissue using immunohistochemistry, and analyze the correlation between them.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
confirmed treated or untreated renal cell carcinoma patients;
68Ga-PSMA PET/CT and 18F-FDG PET/CT within two weeks;
signed written consent.
Exclusion Criteria:
pregnancy;
breastfeeding;
known allergy against PSMA
any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu, MD
Phone
86-13611093752
Email
13611093752@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guochang Wang, MD
Phone
86-18516822732
Email
guochang1007@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Organizational Affiliation
Peking Union 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
Zhaohui Zhu, MD
Phone
86-13611093752
Email
13611093752@163.com
First Name & Middle Initial & Last Name & Degree
Guochang Wang, MD
Phone
86-18516822732
Email
guochang1007@163.com
12. IPD Sharing Statement
Learn more about this trial
Diagnosis of Renal Cell Carcinoma on 68Ga-PSMA PET-CT and Radioligand Therapy With 177Lu-EB-PSMA-617
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