Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

SamariumKyphoplastyPain managementBone metastasesHistologically proven malignancy in the primary siteRadiographic evidence of bone metastasisSignificant pain equal or more than score 5Karnofsky Performance status >40The patient must sign a study specific informed consent

Outcome Measures

Primary Outcomes (1)

To determine the effect of intravertebral injection of Samarium on the relief of pain
Measuring the pain by the Visual Analogue Scale
6 months

Study Arms (1)

Samarium (153SM)

EXPERIMENTAL

Injection of Samarium (153SM)

Drug: Samarium (153SM)

Interventions

Samarium (153SM)Drug

The Samarium is introduced into the vertebral cavity using a 2-way valve by the radiation oncologist. The cement is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon.

Samarium (153SM)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The patient must be 18 years of age or older
The patient must have histologically proven malignancy in the primary site (breast, prostate, or lung)

Sponsors & Collaborators

New York Presbyterian Brooklyn Methodist Hospital
Otherlead

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

MeSH Terms

Conditions

NeoplasmsNeoplasm MetastasisPainAgnosia

Interventions

SamariumSamarium-153

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

Hani Ashamalla, MD, FCCP
New York Presbyterian Brooklyn Methodist Hospital
PRINCIPAL INVESTIGATOR

Enrollment

29 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Chairman of Radiation Oncology

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

May 2006

Date type not reported

This date has not been verified as actual or estimated.

Effect of Samarium on the Relief of Pain Due to Vertebral Metastases

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Samarium (153SM)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Samarium (153SM)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations