Intra-operative Radiation Therapy (IORT) in patients with spinal metastasis

First Experience of Intra-operative Radiation Therapy (IORT) during Kyphoplasty in Patients with Spinal Metastasis in Iran

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160108025901N1

Enrollment

Registered

2019-12-12

Start date

2019-11-30

Completion date

Unknown

Last updated

2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal metastasis.

Interventions

All of the predicted ten patients with spinal metastasis will be candidates of Kyphoplasty surgical procedure and will receive IORT by individualized applicators with specific dosage based on patient'

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of spinal metastasis by radiological evaluation Confirmed diagnosis of spinal metastasis by histopathological evaluation

Exclusion criteria

Exclusion criteria: Previous history of Intra-operative Radiation therapy (IORT) to the same involved location Presence of primary bone tumors or neural tissue tumors of spine Presence of any local soft tissue infection or systemic infection Presence of underlying anatomic disorder of spinal column

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: Pre-operative period; 2nd week, 1st month, 2nd month and 6 month post-operative period. Method of measurement: Visual Assessment Score (VAS) questionnaire.;Individual's ability of performance. Timepoint: Pre-operative period; 2nd week, 1st month, 2nd month and 6 month post-operative period. Method of measurement: Karnofsky Performance Scale (KPS) questionnaire.;Neurological status. Timepoint: Pre- and post-operative period. Method of measurement: Neurological examination.;Assessment of patient's disability. Timepoint: Pre-operative period; 2nd week, 1st month, 2nd month and 6 month post-operative period. Method of measurement: Oswestry Disability Index (ODI) questionnaire.	—

Measure

Time frame

Pain. Timepoint: Pre-operative period; 2nd week, 1st month, 2nd month and 6 month post-operative period. Method of measurement: Visual Assessment Score (VAS) questionnaire.;Individual's ability of performance. Timepoint: Pre-operative period; 2nd week, 1st month, 2nd month and 6 month post-operative period. Method of measurement: Karnofsky Performance Scale (KPS) questionnaire.;Neurological status. Timepoint: Pre- and post-operative period. Method of measurement: Neurological examination.;Assessment of patient's disability. Timepoint: Pre-operative period; 2nd week, 1st month, 2nd month and 6 month post-operative period. Method of measurement: Oswestry Disability Index (ODI) questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Nikouei

Shahid Beheshti University of Medical Sciences

amirnikouei@sbmu.ac.ir+98 21 2271 8001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026