Health Condition 1: D169- Benign neoplasm of bone and articular cartilage, unspecified
Conditions
Interventions
Intervention1: Intralesion Zoledronic Acid: Histopathologically Confirmed Giant Cell Tumour Patients fulfilling inclusion criteria will be subjected to intralesional Zoledronic Acid 4mg. Participants
Sponsors
All India Institute of Medical Sciences , Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1. All the patients of biopsy proven GCT with aggressiveness on radiology (campanacci grade 3) will be included 2. Patient who consents for the study 3. Male or female > 18 years of age 4. Histologically proven GCT of axial and appendicular skeleton 5. Recurrent GCT 6. Pathological fracture in GCT 7. Patient with normal renal function test and serum calcium levels 8. Patients who comply with adequate follow-up
Exclusion criteria
Exclusion criteria: ï?§ Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix ï?§ Known hypersensitivity reaction to drug used ï?§ Pregnancy or lactating ï?§ Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome measures Radiological outcome ï?§ Xray- size reduction, increase in marginal sclerosis, increase in calcification ï?§ MRI- RECIST criterion and CHOI criterion Histopathological response ï?§ Huvoâ??s criterion for necrosis in the tumor ï?§ Ratio of stromal cells to giant cellsTimepoint: at 6 weeks, 12 weeks and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| NOT APPLICABLETimepoint: NOT APPLICABLE | — |
Countries
India
Contacts
Public ContactDr Mohit Dhingra
AIIMS Rishikesh
Outcome results
None listed