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NCT Number: NCT07144748

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital, Beijing, Beijing 100730

Beijing, 100730, China

Location status: Recruiting

Location contact

Wenjia Zhu, MD

CONTACT

[email protected]

+86 18614080164

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 y
  • Histopathologically confirmed cancer (histopathologically proven primary tumors or metastases or radiologically unequivocal metastatic lesions of histologically proven primary tumors)
  • Expected survival of at least 3 months
  • ECOG ≤ 2
  • Written informed consent provided for participation in the trial
  • In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion criteria

  • 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 the procedures.
  • Pregnancy or breastfeeding.
  • Severe claustrophobia.

Treatment and study plan

68Ga-NYM096 PET/CT

Other

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.

Primary outcomes

  1. Uptake characteristics (quantitative analysis) of tumor lesions including primary and metastatic lesions identified on 68Ga-NYM096 PET/CT

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Huo, MD

CONTACT

[email protected]

+86 18612672038

Wenjia Zhu, MD

CONTACT

[email protected]

+86 18614080164

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

68Ga-NYM096 PET/CT: Tracer Uptake in Various Kinds of Cancer

Acronym: NYCRVT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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