Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis

Tracking Information
First Submitted Date ICMJE	December 19, 2012
First Posted Date ICMJE	December 31, 2012
Results First Submitted Date	January 23, 2018
Results First Posted Date	March 20, 2018
Last Update Posted Date	March 20, 2018
Study Start Date ICMJE	January 2013
Actual Primary Completion Date	July 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 20, 2018)	Maximum Radiation Dose [ Time Frame: 1 year ]; 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
Original Primary Outcome Measures ICMJE; (submitted: December 21, 2012)	feasibility of High Dose Rate (HDR) treatment [ Time Frame: 1 year ]; of spine lesions using catheters placed under imageguided navigational techniques, to provide improved dosimetric coverage of spinal lesions such that. In terms of technical feasibility, a patient is regarded as being successfully treated if the target D90 is ≥ 80% AND the cord/cauda max dose is 8 Gy.
Change History	Complete list of historical versions of study NCT01757717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 20, 2018)	Number of Grade 3 of Higher Toxicities [ Time Frame: 1 year ]; For previously irradiated lesions of the spine and/or pelvis, defined as an acceptable level of severe toxicity (both acute and late effects) in the setting of HDR brachytherapy treatment. Severe toxicity will be defined as ≥ grade 3 NCI CTCAE v 4.0 toxicity that is at least possibly related to treatment
Original Secondary Outcome Measures ICMJE; (submitted: December 21, 2012)	Toxicity of HDR brachytherapy [ Time Frame: 1 year ]; for previously irradiated lesions of the spine, defined as an acceptable level of severe toxicity (both acute and late effects) in the setting of HDR brachytherapy treatment. Severe toxicity will be defined as ≥ grade 3 NCI CTCAE v 4.0 toxicity that is at least possibly related to treatment
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis
Official Title ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
Condition ICMJE	Metastatic or Recurrent Lesions in the Spine; Metastatic or Recurrent Lesions in the Pelvis
Intervention ICMJE	Radiation: Ir-192 high dose rate (HDR); 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.
Study Arms	Experimental: Ir-192 high dose rate (HDR); 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.; Intervention: Radiation: Ir-192 high dose rate (HDR)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 25, 2017)	3
Original Estimated Enrollment ICMJE; (submitted: December 21, 2012)	20
Actual Study Completion Date	July 2017
Actual Primary Completion Date	July 2017 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patients must have histologic proof of a malignancy suitable for radiation therapy.; Patients must have received prior external beam radiation therapy to the region proposed for HDR brachytherapy treatment; evaluation of doses previously delivered to spinal cord/cauda equine, pelvis, and other critical structures (bowel, kidneys, rectum) will be taken into consideration.; If repeat irradiation would exceed any normal tissue constraint set by MSKCC Radiation Oncology Department dose constraint criteria, the patient will potentially be eligible.; If the total prior radiation dose to the cord or pelvis exceeds 100 Gy BED equivalent, the patient will be potentially eligible, where a total of 100 BED Gy equivalent is determined by the biological equivalent dose (BED) calculation; BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord late effect and equals 2. [Rades 2005, Nieder 2005, Sahgal 2012]; KPS ≥ 60; Age ≥ 18 years old Exclusion Criteria: Patients who may receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by MSKCC Radiation Oncology Department dose constraint criteria.; Patients with kyphoplasty cement or hardware that would preclude effective catheter placement.; Patients with paraspinal extension of disease with visceral involvement.; Abnormal complete blood count. Any of the following:; Platelet count < 75,000/ml; Hb level < 9gm/dl; WBC < 3.5/ml; Abnormal coagulation profile: INR > 2.5 and/or PTT > 80; Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded.; Contraindications to general anesthesia
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01757717
Other Study ID Numbers ICMJE	12-260
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Memorial Sloan Kettering Cancer Center
Study Sponsor ICMJE	Memorial Sloan Kettering Cancer Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Yoshiya Yamada, MD Memorial Sloan Kettering Cancer Center
PRS Account	Memorial Sloan Kettering Cancer Center
Verification Date	July 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP