68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal Leision
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
This is a prospective, single-center, single-arm, diagnostic phase 2 study aimed at evaluating the sensitivity and specificity of 68Ga-NYM096 PET/CT in detecting clear cell renal cell carcinoma (ccRCC) in patients with complex renal cysts who are scheduled for surgical resection. The study will use histopathological diagnosis as the reference standard to assess the diagnostic accuracy of 68Ga-NYM096 PET/CT in identifying ccRCC within operable complex renal cystic lesion. The findings will provide critical insights into the performance of 68Ga-NYM096 PET/CT as a non-invasive imaging tool for the preoperative detection of ccRCC in this patient population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 y
Presence of complex renal cyst (Bosniak category II or higher)
Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
Expected survival of at least 3 months
Disqualifiers
On VEGF TKI treatment less than 1 week before 68Ga-NYM096 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NYM096. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NYM096 PET/CT is required.
Intercurrent medical condition that renders the patient ineligible for surgery.
Pregnancy or breastfeeding.
Severe claustrophobia.
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-NYM096 PET/CT
Diagnostic testParticipants will be administered a single, intravenous bolus of 68Ga-NYM096 The recommended administered activity of 68Ga-NYM096 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-NYM096 administration.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: 68Ga-NYM096 PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Binary reading of renal lesions identified on 68Ga-NYM096 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 completion2
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 completionSecondary outcomes
1
SUVmax of renal lesions identified on 68Ga-NYM096 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 completion2
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
Time frame
From study completion to 1 month after completion3
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 completion4
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 completionSponsors and contacts
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Source ClinicalTrials.gov