Imaging method for diagnosing liver cancer

A Study of [68Ga]Ga-NOTA-RG2 PET Imaging in the Diagnosis of Hepatocellular

This study is testing a new imaging method to see if it can better diagnose liver cancer in patients who might have the disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai)
• Trial ID: NCT06148155 on ClinicalTrials.gov

What this trial studies

This study aims to establish and optimize the imaging method using [68Ga]Ga-NOTA-RG2 PET imaging to evaluate its effectiveness in diagnosing hepatocellular carcinoma. The research focuses on understanding the physiological and pathological distribution characteristics of this imaging agent. Patients with suspected liver cancer will undergo this imaging technique to assess its diagnostic efficacy compared to traditional methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with suspected or confirmed hepatocellular carcinoma who have not undergone surgery.

Not a fit: Patients receiving anti-tumor therapy or those with severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this imaging method could lead to earlier and more accurate diagnosis of hepatocellular carcinoma, improving patient outcomes.

How similar studies have performed: Other studies using advanced PET imaging techniques have shown promise in improving cancer diagnosis, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Hepatocellular carcinoma patients

  1. Age between 18 and 65 years old, gender is not limited.
  2. Patients with suspicious intrahepatic spaces detected by MR and considered to be hepatocellular carcinoma with AFP\>200 ug/L who have not undergone surgery.
  3. Patients with hepatocellular carcinoma confirmed by puncture pathology
  4. Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
  5. Willingness and ability to cooperate with all programs of the study.

Exclusion Criteria:

* Subjects meeting any of the following criteria will be excluded from the study:

  1. Patients receiving anti-tumor therapy prior to the PET/CT scan.
  2. Suffering from severe other neurological disorders, or gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, immunodeficiency, and other serious diseases.
  3. Alternative subjects with conditions that contraindicate PET/CT scanning. This includes, but is not limited to, elevated blood glucose that is not effectively controlled; pregnant, lactating, or breastfeeding women; those who are unable to receive repeated intravenous injections; those who may be hypersensitive to the drug and its components (including a history of severe allergies or anaphylactic reactions, especially to the drug being examined); and hermetic phobias.
  4. Within the past year, have participated in other research protocols or clinical care, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 mSv.
  5. Alternative subjects have undergone major surgery within the last 3 months; experimental drug or device therapy (of uncertain efficacy or safety) within 1 month
  6. The alternate subject has any clinical condition that, in the opinion of the Sponsor of this study, may cause or has the potential to cause harm from this agent.

Where this trial is running

Shanghai

• Huashan Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Fang Xie, PhD — Huashan Hospital
• Study coordinator: Yihui Guan

Conditions Hepatocellular Carcinoma; Positron-Emission Tomography