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Trial Title:
68Ga-NY104 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses
NCT ID:
NCT05879510
Condition:
Clear Cell Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
68Ga-NY104
PET/CT
renal mass
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
68Ga-NY104 PET/CT
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.
Arm group label:
68Ga-NY104 PET/CT
Other name:
68Ga-NYM005 PET/CT
Summary:
This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients
who have renal masses scheduled for surgical resection. The goal is to determine the
sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal
cell carcinoma using histopathological diagnosis as ground truth, in patients with
operable renal masses.
Detailed description:
This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients
with renal masses scheduled for surgical resection. Each patient will receive one dose of
68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.
Additionally, prior to resection of the tumor, contrast-enhanced CT imaging of the
abdomen, and if clinically warranted, or as part of the local standard of care, of the
chest, will be performed. Both imaging modalities will be performed prior to resection of
the kidney(s). PET/CT studies will be interpreted by two readers and diagnostic CT will
be interpreted by one reader, all of whom will provide independent and blinded
interpretations. Imaging interpretations and histopathologic evaluation data will be used
to estimate the sensitivity, specificity, and predictive value (primary and secondary
objectives) of each modality. The exploration into the detection of metastases by
68Ga-NY104 PET/CT in comparison to diagnostic CT will also be performed.
The pathologist will identify representative tumor tissue for the determination of
histology, grading, and CAIX expression.
63 patients will be recruited in Peking Union Medical College Hospital. This study will
be conducted according to local regulations and laws, the ethical principles that have
their origin in the Declaration of Helsinki, and the principles of Good Clinical
Practice.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 y
2. Presence of a renal mass
3. Scheduled for surgical resection of renal mass (partial or total nephrectomy, open,
laparoscopic, or robot-assisted technique)
4. Expected survival of at least 3 months
5. ECOG ≤ 2
6. Written informed consent provided for participation in the trial
7. In the opinion of investigator, willing and able to comply with required study
procedures.
Exclusion Criteria:
1. 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.
2. Intercurrent medical condition that renders the patient ineligible for surgery.
3. Pregnancy or breastfeeding.
4. Severe claustrophobia.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenjia Zhu, MD
Email:
zhuwenjia_pumc@163.com
Start date:
August 1, 2023
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Peking Union Medical College 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/NCT05879510
