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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
63
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.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGBinary reading of renal lesions identified on 68Ga-NY104 PET/CT
Define lesion as PET positive or PET negative lesion. The kidney lesion is designated as positive if the SUVmax of kidney lesions is higher than that of liver (reference).
Time frame: From study completion to 1 month after completion
Histological classification of operated renal lesions
The histological classification of operated renal lesions will be determined according to WHO classification of tumors, Feb 2004.
Time frame: From study completion to 1 month after completion
SUVmax of renal lesions identified on 68Ga-NY104 PET/CT
For kidney lesions, the tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest (ROI) over the lesion using a threshold of 40% SUVmax. The ROI should be drawn with caution not to include any adjacent normal kidney parenchyma.
Time frame: From study completion to 1 month after completion
SUVmax of liver uptake on 68Ga-NY104 PET/CT
The liver uptake (SUVmax (liver)) is used as the references to define PET positive lesions. It is measured by placing a 3-cm region of interest in right lobe at the level of porta hepatis. Focal lesion should be avoided if present.
Time frame: From study completion to 1 month after completion
Tumor grade of operated renal lesions
The tumor grade of operated renal lesions will be determined according to Fuhrmann grading system
Time frame: From study completion to 1 month after completion
Intensity of CAIX staining of operated renal lesions
The intensity of CAIX staining of operated renal lesions will be based on a 4-point scale from 0-3 according to the method of Bui et al, 2003
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Time frame: From study completion to 1 month after completion
Extent of CAIX staining of operated renal lesions
The extent of CAIX staining of operated renal lesions will be determined by the percentage of the target tissue sample that have positive CAIX expression according to the method of Bui et al, 2003
Time frame: From study completion to 1 month after completion
Binary reading of renal lesions identified on diagnostic CT
A tumor will be described as clear cell renal carcinoma on a triphasic CT if one of the following two parameters is applicable: * Significant (\>85 HU) enhancement in the cortico-medullary phase * Significant (\>45 HU) enhancement in the parenchyma / excretory phase
Time frame: From study completion to 1 month after completion
Size of renal lesions identified on diagnostic CT
The longest diameter of the tumor will be measured on diagnostic CT
Time frame: From study completion to 1 month after completion
Number of metastatic lesions identified on 68Ga-NY104 PET/CT
For metastasis evaluation, any focal accumulation of 68Ga-NY104 outside the kidneys that cannot be explained by physiologic uptake is interpreted as focal lesion. The SUVmax and tumor-to-background should be evaluated. Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue. Any focal lesion identified on 68Ga-NY104 PET will be considered to be positive for metastasis if SUVmax (lesion) is no less than SUVmax (liver) or tumor-to-background ratio is higher than 1.
Time frame: From study completion to 1 month after completion
Location of metastatic lesions identified on 68Ga-NY104 PET/CT
For metastasis evaluation, any focal accumulation of 68Ga-NY104 outside the kidneys that cannot be explained by physiologic uptake is interpreted as focal lesion. The SUVmax and tumor-to-background should be evaluated. Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue. Any focal lesion identified on 68Ga-NY104 PET will be considered to be positive for metastasis if SUVmax (lesion) is no less than SUVmax (liver) or tumor-to-background ratio is higher than 1.
Time frame: From study completion to 1 month after completion
Szie of metastatic lesions identified on 68Ga-NY104 PET/CT
For metastasis evaluation, any focal accumulation of 68Ga-NY104 outside the kidneys that cannot be explained by physiologic uptake is interpreted as focal lesion. The SUVmax and tumor-to-background should be evaluated. Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue. Any focal lesion identified on 68Ga-NY104 PET will be considered to be positive for metastasis if SUVmax (lesion) is no less than SUVmax (liver) or tumor-to-background ratio is higher than 1.
Time frame: From study completion to 1 month after completion
Number of metastatic lesions on diagnostic CT
The number of metastatic lesions on diagnostic CT will be determined by radiologist according to the typical location, enhancement pattern of the lesions.
Time frame: From study completion to 1 month after completion
Location of metastatic lesions on diagnostic CT
The number of metastatic lesions on diagnostic CT will be determined by radiologist according to the typical location, enhancement pattern of the lesions.
Time frame: From study completion to 1 month after completion
Size of metastatic lesions on diagnostic CT
The number of metastatic lesions on diagnostic CT will be determined by radiologist according to the typical location, enhancement pattern of the lesions.
Time frame: From study completion to 1 month after completion