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

Completed · Not applicable

Conditions studied: Metastatic or Recurrent Lesions in the Spine, Metastatic or Recurrent Lesions in the Pelvis

In brief

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.

Key facts

Study ID

NCT01757717

Run by

Memorial Sloan Kettering Cancer Center

People needed

3

Starts

2013-01-01

Expected to finish

2017-07-01

Last updated by the study team

2018-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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