Clinical trial · Interventional
Diagnostic Significance of Single Center, Open and Prospective Evaluation of <Sup>18<Sup>F-FDG PET/CT Dynamic Imaging and Genomic Sequencing in Detecting Metastatic Lesions of Primary Hepatocellular Carcinoma
NCT03636607CI-TRIAL-00087609withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participents enrolled
Summary
Brief summary (as posted)
The aim of this study is to make up for this gap by performing a dynamic scan of 18F-FDG PET/CT on newly diagnosed patients with liver cancer. The lesions and/or metastases are performed for biopsy. Pathological and genomic studies are performed. The differences between tumor images and tissues are compared at the same time. 18F-FDG PET/CT dynamic imaging is explored in primary liver cancer metastases for the diagnostic value.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Positron-Emission Tomography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/CT dynamic scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Non-metastatic group
- description
- PET/CT dynamic scan,needle biopsy and gene detection
- interventionNames
- Diagnostic Test: PET/CT dynamic scan
- type
- EXPERIMENTAL
- label
- Metastatic group
- description
- PET/CT dynamic scan,needle biopsy and gene detection
- interventionNames
- Diagnostic Test: PET/CT dynamic scan
Primary outcomes (1)
- measure
- Calculating the overall diagnostic sensitivity and specificity and ROC
- timeFrame
- 60 minutes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Accurately diagnosing primary liver cancer according to pathological diagnostic criteria or clinical diagnostic criteria. * Tumor volume (\> 1 cm) displayed by enhanced CT or MRI or liver mass confirmed by arteriography . * For patients considering distant metastases, trunk metastases need to be confirmed by CT examination. Bone metastases need to be confirmed by whole-body bone scan. Brain metastases need to be confirmed with characteristic metastatic tumors by MRI. * The age is more than 18 years old and less than 65 years old. There is no gender restriction. * Untreated patients who have not received surgery, interventional therapy, chemotherapy, biotherapy, and radiation therapy. * Physical condition score ECOG: 0-2; no major organ dysfunction; oxygen partial pressure ≥ 10.64kPa; white blood cell count≥ 4 × 109/L; hemoglobin ≥ 9.5g/dL; neutrophil absolute count ≥ 1.5 × 109 / L; platelet count ≥ 100 × 109 / L; total bilirubin ≤ 1.5 times of the upper limit of normal value; creatinine ≤ 1.25 times of the upper limit of normal value; and creatinine clearance ≥ 60ml / min. * Be able to obtain complete follow-up information, understand the situation of this study and sign informed consent. Exclusion Criteria: * Poorly controlled diabetics (fasting blood glucose levels \> 200 mg/dL). * In addition to four types of malignant tumors that can be treated with radical resection, such as cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma in situ, and organ localized prostate cancer, suffering from any other malignant tumors within 5 years. * Breastfeeding and/or pregnant women. * Patients with severe bleeding tendencies (prothrombin time less than 50%, cannot be corrected by treatment with vitamin K, etc.). * Recent severe hemoptysis, severe cough, dyspnea or patients are not able to cooperate. * People with severe emphysema, pulmonary congestion, and pulmonary heart disease. * Researchers believe that the subject may not be able to complete this study or may not be able to comply with the requirements of this study (for management reasons or other reasons).
References
Publications (0)
Data not yet available
No reference posted for this study.