Diagnostic Efficacy and Prognostic Value of 18F-FDG PET/CT (MR) in Pediatric Solid Blastoma

Neuroblastoma Clinical Trial

Official title:

Diagnostic Efficacy and Prognostic Value of 18F-FDG PET/CT (MR) in Pediatric Solid Blastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06190574
• Other study ID #: XLan-1218
• Status: Completed
• Start date: July 30, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

the primary histologic origin of extracranial solid tumors in children is malignant embryonic cells, including Neuroblastoma (NB) , Hepatoblastoma(HB), and kidney, wilms' tumor(WT). Their main clinical symptoms are large abdominal masses, the most common lymph node metastasis . NB accounts for 15% of childhood cancer deaths, but some low-risk NB can disappear on its own. The International Neuroblastoma Risk Group Staging System (INRGSS) was used to determine Risk before NB treatment, whereas the INRGSS was entirely based on the Neuroblastoma diagnosis, illustrating the importance of imaging in the assessment of NB.18F-FDG is the most commonly used agent in PET imaging of tumor. It can reflect the glucose metabolism of tumor and is widely used in the diagnosis, staging, evaluation of curative effect and prognosis prediction of tumor In this study, the investigators retrospectively analyzed 18F-FDG PET/CT or PET/MRI images from patients with NB, HB, and WT. The investigators sought to assess whether these images provide useful information for diagnosis and prognosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2023
• Est. primary completion date: September 30, 2023
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

1. age < 18 years,

2. have pathological results or definite clinical diagnosis as the gold standard.

Exclusion Criteria:

1. had surgery or chemotherapy before imaging,

2. accompanying other tumors,

3. diabetic patients or patients with fasting blood glucose = 200 mg/dL.

Related Conditions & MeSH terms

• 18F-FDG
• Hepatoblastoma
• Neuroblastoma
• Wilms Tumor

Intervention

Other:
• Telephone follow-up
Telephone follow-up

Locations

Country	Name	City	State
China	China, Hubei Province	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Region of Interest (ROI)	The presence of non-physiological uptake or uptake in a tissue structure can be considered pathological. The lesion intake is higher than the health organization and is classified as clearly positive. The lesion and the surrounding normal tissue ROI, measure the SUV, TLG and MTV.	up to 2 years
Primary	Sensitivity and specificity of diagnosis and staging	Comparison of the high uptake portion of a pet image suspected to be a histiocytoma for consistency with pathological findings, using the pathological section as the gold standard to calculate the sensitivity and specificity of the diagnostic.	up to 2 years