68Ga-NYM096 PET/CT in Various Kinds of Cancer (NYCRVT)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Cancer

Treatments: Other: 68Ga-NYM096 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT07144748

K8490

Details and patient eligibility

About

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.

Full description

This is a prospective, single-center study designed to evaluate the uptake characteristics of 68Ga-NYM096 PET/CT in various kinds of tumors including primary and metastatic lesions. Each patient will receive a single intravenous dose of 68Ga-NYM096, followed by dedicated whole-body PET/CT imaging. 68Ga-NYM096 PET/CT scans were requested by referring physicians according to individual clinical indications that were considered insufficiently covered by 18F-FDG PET/CT or other imaging modalities.

Quantitative analyses will be applied to assess the uptake of 68Ga-NYM096 in primary and metastatic lesions in different tumor types, including lesion number, SUVmax (40% isocontour), tumor-to-background ratio (TBR).

120 patients with histopathologically proven primary tumors or metastases or radiologically unequivocal metastatic lesions of histologically proven primary tumors 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

68Ga-NYM096 PET/CT

Experimental group

Description:

Each patient will receive one dose of 68Ga-NYM096 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.

Treatment:

Other: 68Ga-NYM096 PET/CT