The Value of Preoperative Diagnosis and Prognostic Prediction Based on Radiomics of Giant Cell Tumor of Spine

NCT04952818 — Completed, 100 participants, Peking University Third Hospital

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Radiomics Based on Preoperative Imaging of Giant Cell Tumor of the Spine to Predict the Early Recurrence and Survival of Giant Cell Tumor of the Spine After Surgery, and the Expression Levels of P53, VEGF, RANK, RANKL and Other Prognostic-related Molecular Markers.

Registry	NCT04952818
Status	Completed
Study type	Observational
Enrollment	100 (Actual)
Sponsor	Peking University Third Hospital (Other)
Conditions	Spinal Tumor
Interventions	RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand) (Diagnostic test)
Dates	start 2020-01-01, primary completion 2020-03-01, completion 2020-03-01, first posted 2021-07-07, last updated 2021-07-07
Locations	1 site in China

-Summary

1. Exploit CT (plain scan), enhanced CT and fMRI based radiomic biomarkers, explore their correlation with the prognostic molecular markers of spinal GCTB(p53/vegf/rank/rankl…), and help accurate diagnosis of GCTB.
2. Exploring a new method of preoperative risk stratification for spinal GCTB, and establishing radiomic model combined with clinical features. Exploring the GCTB biological behavior prediction model and the prognosis prediction of GCTB.

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+Detailed description

This study intends to conduct a systematic review of patients with spinal GCTB who have undergone standardized imaging (CT or MRI) in our hospital since 2006 to obtain case samples, conduct standardized clinical and imaging data extraction and analysis, and fully integrate histopathology and clinical follow-up results. To preliminarily explore the value of postoperative imaging-based radiomics markers in the preoperative precise diagnosis of spinal GCTB, risk stratification and prediction of tumor biological behavior.

+Arms and interventions

Arm	Type	Interventions	Description
RANK/RANKL low expression		Diagnostic Test: RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand)
RANK/RANKL high expression		Diagnostic Test: RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand)

RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand) (Diagnostic test): Immunohistochemical staining was performed using the following antibodies: anti-RANK antibody from Bioss Company (No.bs-2695R) and anti-RANKL antibody from Abcam (No.ab222215).

+Outcome measures

Primary outcomes

RANK/RANKL [2020]: Grade:low;high(Receptor Activator of Nuclear factor Kappa-Β/Ligand)
VEGF [2020]: Grade:low;high(Vascular Endothelial Growth Factors)
p53 [2020]: Grade:low;high(Tumor Suppressor Protein)

Secondary outcomes

Recurrence [2020]: recurrence group/non-recurrence group

+Eligibility

Sex: All, ages: 1 Year to 100 Years

Inclusion Criteria:

* Patients diagnosed with spinal GCTB who underwent surgical resection or biopsy without preoperative chemotherapy or radiotherapy were included in this study.

Exclusion Criteria:

* i) The CT scan was performed more than 1 week before surgery ii) Poor image quality. Such as surrounding structure artifacts; iii) The remaining tumor tissue in the postoperative paraffin specimen is too little to be used for reanalysis; iv) Cases with negative H3F3A (H3 histone, family 3A) staining were excluded; v) Incomplete clinical information.

+Locations (1)

Facility	City	Country	Status
Peking University third hospital	Beijing, Please Select An Option Below	China

+Investigators

Ning Lang, Study chair, Peking University Third Hospital