68Ga-NYM096 PET/CT: Participants 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.
Study summary
This is a prospective, single-center study aimed at evaluating the uptake characteristics of 68Ga-NYM096 PET/CT in various kinds of tumors including primary and metastatic lesions. Based on image analysis, this study will assess the uptake of various kinds of tumors using 68Ga-NYM096 PET/CT. The findings will provide critical insights into the tumor uptake on 68Ga-NYM096 PET/CT to identify the most promising indications for future application.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 y
2. Histopathologically confirmed cancer (histopathologically proven primary tumors or metastases or radiologically unequivocal metastatic lesions of histologically proven primary tumors)
3. Expected survival of at least 3 months
4. ECOG ≤ 2
5. Written informed consent provided for participation in the trial
6. 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-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.
2. Intercurrent medical condition that renders the patient ineligible for the procedures.
3. Pregnancy or breastfeeding.
4. Severe claustrophobia.
Primary outcome measure(s)
Uptake characteristics (quantitative analysis) of tumor lesions including primary and metastatic lesions identified on 68Ga-NYM096 PET/CT — From study completion to 1 month after completion For tumor lesions, the tracer uptake is quantified using maximal and mean standard uptake value by drawing a 3-dimensional region of interest (ROI) over the lesion using a threshold of 40% SUVmax. Tumor-to-background ratios (TBRs) should also be evaluated. Adjacent normal tissue is the preferred background tissue. If not available, the blood pool should be designated as background tissue.
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital, Beijing, Beijing 100730
Beijing
China
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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