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

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.

Study Overview

• Status: Completed
• Conditions: Neuroblastoma; Wilms Tumor; Hepatoblastoma; 18F-FDG
• Intervention / Treatment: Other: Telephone follow-up

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • China, Hubei Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

We reviewed the electronic medical record and imaging data of 47 children who underwent 18F- FDG PET/CT or PET/MR for the diagnosis of suspected NB, HB or WT from Jan 1, 2013, to Aug 30, 2021.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Xiaoli Lan, PhD, Study Principal Investigator Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Neoplasms, Glandular and Epithelial; Genetic Diseases, Inborn; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Kidney Neoplasms; Neoplastic Syndromes, Hereditary; Neoplasms, Complex and Mixed; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neuroblastoma; Wilms Tumor; Hepatoblastoma
• Other Study ID Numbers: XLan-1218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No