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NCT Number: NCT06763354

The Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging

The study was planned to include patients with bladder tumors attending the Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, from 09/2024 to 12/2025. Patient demographics will be collected, patients will be monitored for medical history and co-morbidities, co-morbid medications or treatments, vital signs, and cystoscopy will be performed. Patients meeting the inclusion criteria will be included in this study. Patients will receive PET/MR imaging after bladder instillation of [68Ga] NOTA-DNA multivalent SGC8 injection to assess the effectiveness of bladder tumor imaging and to evaluate the safety of [68Ga] NOTA-DNA multivalent SGC8.

The primary study was the ability of gallium [68Ga] NOTA-DNA multivalent SGC8 injection to provide tumor-specific imaging of bladder tumor patients of different genders, with a compliance rate of more than 80% when compared to the gold standard TUR pathology. To study the safety of gallium[68Ga] NOTA-DNA multivalent SGC8 injection; to assess the correlation between gallium[68Ga] NOTA-DNA multivalent SGC8 imaging ability and clinical parameters; to study the ability of gallium [68Ga]NOTA-DNA multivalent SGC8 to differentiate between bladder tumor foci and inflammatory foci; to explore the gallium [68Ga]NOTA- DNA multivalent SGC8 target PTK7 receptor protein expression in bladder tumors and the correlation between tumor differentiation and malignancy.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Voluntary enrolment with signed informed consent
  • Age >18 years, <85 years
  • Cystoscopic diagnosis of bladder tumour with imaging and pathology reports not required
  • Willingness and ability to follow trial protocol requirements.

Exclusion criteria

  • Pregnancy, breastfeeding, severe hepatic, renal insufficiency and children
  • Hypersensitivity to the test drug, allergy or allergy to multiple drugs

Treatment and study plan

Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection

Radiation

On the examination bed, the patient was placed in the lying truncated position, the perineum was disinfected with a towel, and a double-lumen urinary catheter was inserted via the perineum.Inject 50ml saline to clean the bladder once, open the drainage bag to drain.1mci SGC8 was dissolved in 50ml physiological saline. The drainage bag was clamped shut and 50ml of developer was injected into the bladder through the catheter, followed by 10ml of gas or saline (all developer in the ureter was injected into the bladder. The catheter was closed for 1 hour, during which time the patient was placed in the flat position, left lateral position, right lateral position, and supine position changing positions every 15 minutes.After 1 hour, the drainage bag was opened, the bladder was emptied with radioactive fluid, and the urine bag was replaced.

Primary outcomes

  1. Tumor specific lighting ability of Gallium[68Ga]NOTA-DNA Multivalent SGC8

    Time frame: 2 year

    Number of patients whose tumors are lightened under PET/MR with Gallium[68Ga]NOTA-DNA Multivalent SGC8

Secondary outcomes

  1. Safety of Gallium[68Ga]NOTA-DNA Multivalent SGC8

    Time frame: 2 Year

    Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation

  2. Accuracy in clinical parameters of Gallium[68Ga] NOTA-DNA multivalent SGC8

    Time frame: 2 Year

    Correlation between gallium[68Ga] NOTA-DNA multivalent SGC8 images and clinical parameters

  3. Foci-distinguishing ability of Gallium [68Ga]NOTA-DNA multivalent SGC8

    Time frame: 2 Year

    The ability of gallium [68Ga]NOTA-DNA multivalent SGC8 to differentiate between bladder tumor foci and inflammatory foci

  4. The expression of PTK7 in bladder tumor tissues

    Time frame: 2 Year

    The expression of [68Ga]-NOTA-SGC8 target PTK7 receptor protein in bladder tumor tissues

Study contacts

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

Peifeng Liu

CONTACT

[email protected]

86 13512116782

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

An Exploratory Clinical Study of the Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2025
Registry last updated
Mar 14, 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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