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A Clinical Study Evaluating the Safety, Tolerability, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy of 68Ga-NODAGA-SNA009 in Patients with Colorectal Cancer

A Clinical Study Evaluating the Safety, Tolerability, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy of 68Ga-NODAGA-SNA009 in Patients with Colorectal Cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110404
Enrollment
Unknown
Registered
2025-10-13
Start date
2025-10-28
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Interventions

Test group:68Ga-NODAGA-SNA009 and 18F-FDG PET-CT imaging

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years (inclusive). 2. Subjects with capacity for civil conduct who voluntarily participate in this clinical trial and provide written informed consent. 3. Patients with confirmed diagnosis of colorectal cancer. 4. Have not received prior following treatments for the target tumor: tumor resection/radical surgery (excluding diagnostic biopsy), radiotherapy (including brachytherapy), systemic anti-tumor drugs (e.g., chemotherapy, small molecule targeted therapy, monoclonal antibody drugs), or any other investigational therapy from a clinical study. 5. Results from endoscopic/CT/MRI/PET-CT examinations within the past 1 month (if available). 6. Pathological test results within the past 1 year.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with other concurrent malignancies. 2. Patients with uncontrolled severe infection, or those accompanied by other severe underlying diseases. 3. Patients with an expected life expectancy of = 3 months. 4. Pregnant or lactating patients, and patients of childbearing potential who refuse to adopt adequate contraceptive measures during the trial period. 5. Patients deemed by the investigator as unsuitable for participation in this study for other reasons.

Design outcomes

Primary

MeasureTime frame
Medication Safety;Radiation Absorption Dose Characteristics;Biodistribution Profile;PET Imaging Characteristics;

Secondary

MeasureTime frame
The correlation between PET imaging and GPA33 expression levels as measured by immunohistochemistry (IHC);Diagnostic Efficacy;

Countries

China

Contacts

Public ContactDai Dong

Tianjin Medical University Cancer Institute and Hospital

xiandao5502@163.com+86 186 2200 0577

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026