68Ga-N188 PET/CT Imaging in Malignancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [68Ga]N188.
- Who it may be relevant to
- Registry conditions: Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study to Evaluate 68Ga-N188 PET/CT Imaging of Nectin-4 Expression in Malignant Tumors
Overview
The Nectin-4 protein belongs to the cell adhesion factors family and has a tissue-specific expression spectrum in normal human tissues. However, Nectin-4 is overexpressed in various malignancies, especially those of epithelial origins, such as uroepithelial carcinoma, making Nectin-4 a highly specific and significant imaging target for malignancies. \[68Ga\]N188, a novel molecular probe of PET imaging agent that targets Nectin-4, can be used in the diagnosis and research of a wide variety of Nectin-4 high-expression malignancies, including bladder cancer.
Interventions
- Drug [68Ga]N188
68Ga-N188 is injected intravenously with a dose of 0.06-0.08 mCi/kg.
Primary outcome measures
- The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors [Time frame: 1 year]
- The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors [Time frame: 1 year]
Secondary outcome measures (3)
- The dosimetry of 68Ga-N188 [Time frame: 1 year]
- Quantitative evaluation of 68Ga-N188 [Time frame: 1 year]
- Correlation with pathological expression [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- patients with confirmed or suspected cancer;
- 18F-FDG PET/CT within 1 week;
- Signed written informed consent.
Exclusion criteria
- Pregnant and lactating women;
- Female patients plan to become pregnant within 6 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Publications
- Zhang J, Duan X, Chen X, Zhang Z, Sun H, Shou J, Zhao G, Wang J, Ma Y, Yang Y, Tian X, Shen Q, Yu W, He Z, Fan Y, Yang X. Translational PET Imaging of Nectin-4 Expression in Multiple Different Cancers with 68Ga-N188. J Nucl Med. 2024 May 6;65(Suppl 1):12S-18S. doi: 10.2967/jnumed.123.266830. PMID 38719240
Identifiers
NCT: NCT05593107 · [68Ga]N188