This trial is active, not recruiting.

Conditions metastatic or recurrent lesions in the spine, metastatic or recurrent lesions in the pelvis
Treatment ir-192 high dose rate (hdr)
Sponsor Memorial Sloan Kettering Cancer Center
Start date January 2013
End date December 2017
Trial size 20 participants
Trial identifier NCT01757717, 12-260


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
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.

Primary Outcomes

feasibility of High Dose Rate (HDR) treatment
time frame: 1 year

Secondary Outcomes

Toxicity of HDR brachytherapy
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Yoshiya Yamada, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.