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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ir-192 high dose rate (HDR) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ir-192 high dose rate (HDR) | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Radiation Dose | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Grade 3 of Higher Toxicities | 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 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshiya Yamada, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2015 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Radiation Dose | 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 | Posted | Median | Full Range | cord/cauda max dose in Gy | 1 year |
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| Secondary | Number of Grade 3 of Higher Toxicities | 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 | Posted | Number | brachytherapy related complications | 1 year |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 3 | 0 | 3 | 3 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Buttock Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josh Yamada, MD | Memorial Sloan Kettering Cancer Center | 212-639-2950 | yamadaj@mskcc.org |
| Jan 23, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000615087 | Iridium-192 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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