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A Clinical Study Evaluating the Safety, Tolerability, Biodistribution, Radiodose Measurement, and Preliminary Diagnostic Efficacy of 68Ga-DOTA-CTC1 in Patients with Hepatocellular Carcinoma

A Clinical Study Evaluating the Safety, Tolerability, Biodistribution, Radiodose Measurement, and Preliminary Diagnostic Efficacy of 68Ga-DOTA-CTC1 in Patients with Hepatocellular Carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117143
Enrollment
Unknown
Registered
2026-01-20
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Hepatocellular Carcinoma

Interventions

Experimental group:68Ga-DOTA-CTC1 and 18F-FDG PET-CT imaging

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 75 years (including both age limits); 2. Legally competent individuals who voluntarily participate in this clinical study and sign an Informed Consent Form (ICF); 3. Patients with suspected hepatocellular carcinoma based on contrast-enhanced CT or MR imaging; 4. Patients scheduled for surgery or pathological examination within 60 days after imaging, who agree to provide sufficient and suitable tumor tissue samples (formalin-fixed, paraffin-embedded specimens) postoperatively for pathological testing at the research center; 5. Have not received any of the following treatments for this tumor: tumor resection/curative surgery (excluding diagnostic biopsy), radiotherapy (including brachytherapy), systemic anticancer drugs (chemotherapy, small-molecule targeted agents, monoclonal antibodies, etc.), or experimental treatments in other clinical studies.

Exclusion criteria

Exclusion criteria: 1. Patients with other clearly diagnosed malignant tumors; 2. Patients with uncontrolled severe infections or concomitant serious illnesses; 3. Patients with an expected survival period <= 3 months; 4. Pregnant or lactating patients, and patients of childbearing potential who refuse to use appropriate contraceptive measures during this trial; 5. Patients deemed unsuitable for participation in this study by the investigator.

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 GPC3 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