A Pilot Study of Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis
Sponsor study identifier
interventional
3
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)The purpose of this study is to see if using a form of imaging during surgery helps the doctors to guide the placement of radiation catheters more accurately. This method, called "image-guided surgical navigation" may allow the doctors to deliver radiation to the tumor that the patient needs and decrease the amount of radiation delivered to the nearby areas.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2012
Actual (reported)December 31, 2012
Actual (reported)January 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 2017
Actual (reported)July 2017
Actual (reported)March 20, 2018
Actual (reported)Maximum Radiation Dose
Verify feasibility of HDF treatment of spinal and/or pelvic lesions using catheters placed under image-guided navigational techniques, to provide improved dosimetric coverage of lesions such that Cord/Cauda Dmax of \<8 Gy
1 year
Number of Grade 3 of Higher Toxicities
1 year
This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine and/or pelvis that have been maximally treated with external beam radiation therapy.
Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Yoshiya Yamada, MD
Memorial Sloan Kettering Cancer Center
3 participants (actual enrollment reported by the registry).
First Submitted
December 19, 2012
First Posted
December 31, 2012
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)Last Updated
March 20, 2018
Results First Posted
March 20, 2018
Record last verified: 2017-07
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Source: ClinicalTrials.gov.
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