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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Metastatic or Recurrent Lesions in the Spine; Metastatic or Recurrent Lesions in the Pelvis

Treatments: Radiation: Ir-192 high dose rate (HDR)

Study type: Interventional

Funder types: Other

Identifiers

NCT01757717

12-260

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Ir-192 high dose rate (HDR)

Experimental group

Description:

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.

Treatment:

Radiation: Ir-192 high dose rate (HDR)