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

NCT06190574 | Completed

• 1 other identifier: XLan-1218
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

18F-FDG; Neuroblastoma; Hepatoblastoma; Wilms Tumor

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Telephone follow-up OTHER

Telephone follow-up

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• age \< 18 years,
• have pathological results or definite clinical diagnosis as the gold standard.

You may not qualify if:

• had surgery or chemotherapy before imaging,
• accompanying other tumors,
• diabetic patients or patients with fasting blood glucose ≥ 200 mg/dL.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

China, Hubei Province

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Neuroblastoma; Hepatoblastoma; Wilms Tumor

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xiaoli Lan, PhD

  Study Principal Investigator Wuhan Union Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: July 30, 2021
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 19, 2024

Record last verified: 2023-12

Locations

CN (1)