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

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ClinicalTrials.gov Identifier: NCT01757717
Recruitment Status : Completed
First Posted : December 31, 2012
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Metastatic or Recurrent Lesions in the Spine
Metastatic or Recurrent Lesions in the Pelvis
Intervention: Radiation: Ir-192 high dose rate (HDR)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    Ir-192 High Dose Rate (HDR)
STARTED   3 
COMPLETED   3 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.


Baseline Measures
   Ir-192 High Dose Rate (HDR) 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age 
[Units: Years]
Mean (Full Range)
 64 
 (46 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  66.7% 
Male      1  33.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      2  66.7% 
Unknown or Not Reported      1  33.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1  33.3% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      1  33.3% 
More than one race      0   0.0% 
Unknown or Not Reported      1  33.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   3 


  Outcome Measures

1.  Primary:   Maximum Radiation Dose   [ Time Frame: 1 year ]

2.  Secondary:   Number of Grade 3 of Higher Toxicities   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Josh Yamada, MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-2950
e-mail: yamadaj@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01757717     History of Changes
Other Study ID Numbers: 12-260
First Submitted: December 19, 2012
First Posted: December 31, 2012
Results First Submitted: January 23, 2018
Results First Posted: March 20, 2018
Last Update Posted: March 20, 2018