CancerPhase 1/2NCT00374751
Effect of Samarium on the Relief of Pain Due to Vertebral Metastases
A Phase 1/2 study testing Samarium (153SM) in people with Cancer and Metastasis, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
Trial summary
Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the induced cavity with a cement like substance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer, Metastasis, Pain
- What is being tested?
- Samarium (153SM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be 18 years of age or older
- The patient must have histologically proven malignancy in the primary site (breast, prostate, or lung)
- The patient must have a radiographic evidence of bone metastasis, and this must have been performed within 8 weeks prior to enrollment in the study. Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans, magnetic resonance imaging, and PET-CT scans.
- The patient must have an intact anterior wall of spinal canal
- The patient must have significant pain (score 6 or above,)which appears to be related to the radiographically documented metastatic vertebra(e) in concern, as measured by the "Visual Analog Scale"
- The patient must be surgically and medically accepted for vertebroplasty/kyphoplasty operation
Show all 9Show fewer
- Karnofsky Performance status >40
- Expected life expectancy of 6 months or greater, as estimated by the physician in charge.
- The patient must sign a study specific informed consent prior to enrollment
Who cannot join
- Epidural soft tissue component
- Patients with vertebral metastases and with clinical or radiographic evidence of spinal cord or cauda equina impingement (effacement) or compression
- Inability to undergo anesthesia
- Hematologic primary malignancies Patients received systemic radiotherapy (89SR or 153SM)within 30 days prior to enrollmen
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Methodist Hospital
Brooklyn, New York, 11215
About this study
Official title: Phase I/II Study of the Use of Vertebral Intracavitary Cement and Samarium (VICS) for Painful Vertebral Metastases
Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the induced cavity with a cement like substance.
The investigators are studying the effects (good or bad) of adding samarium (a radioactive substance) to the cement that is injected into the induced cavity.
Read the detailed description
Protocol:
- Patients with bone metastases will be identified and discussed in the weekly joint Neuroscience meeting held in Radiation Oncology Department.
- If the patient is eligible to this study, the protocol will be offered to him/her. If the patient accepts; informed consent will be obtained.
- The case will be scheduled jointly by Neurosurgeon and Radiation Oncologist.
- Radiation physicist orders the radioactive samarium.
During the procedure:
- Neurosurgical procedure ( kyphoplasty/vertebroplasty) is performed as standard using . mild general sedation and local anesthesia.
- Once a cavity is identified in fluoroscopy, the trocar is secured. The volume and pressure of the kyphoplasty balloon are recorded.
- According to standard practice; only the radiation team (Radiation oncologist, Physicist) is handling the radioactive material. All work is done under sterile conditions.
- Two mCi. of Samarium is prepared after serial dilution steps under radiation precautions in the department of radiation oncology and material is transferred to OR.
- 0.5ml of "Head Cement" is administered first to act as a seal.
- The Samarium is then introduced into the vertebral cavity using a 2-way valve by the Radiation Oncologist. Total of 0.5ml (Samarium+0.2ml radio opaque material)
- The "Foot cement" (0.5 ml) is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon to flush any remains of radioactivity in the system.
- The two way valve is then removed and the rest of kyphoplasty/vertebroplasty is ensued as per their ordinary protocol.
- Final volume of cement injected is recorded.
- After securing the wound, all devices, syringes, gloves and basins used for handling the radioactive substance are collected in a "red bag" and stored by radiation safety officer in the hot lab. till full radioactive decay.
- The room is scanned after patient's discharge, any spillage should be reported to radiation safety officer and normal procedures for environmental protection are ensued.
Post Procedure:
- Normal neurosurgical recovery room protocol is employed. No radiation precautions needed.
- Patient can be discharged home. No delays because of radiation precautions
- Once patient is cleared, a nuclear imaging scan is obtained with Gamma camera. The ratio of uptake in the vertebra to background is calculated. Moreover, Full body scan is obtained to identify other areas of uptake if any.
- A second nuclear imaging scan is done on the 4th day of the procedure (Two half Lives) to document significant decay and calculate dose.
- MRI/CT scan of the area treated should be done in 4 weeks to assess outcome.
- Clinical follow up is obtained at 2, 4 weeks and in 3 months. Careful pain score assessment is included in each time (Use Study Flow Sheet)
- Conditions
- Cancer, Metastasis, Pain
- Being tested
- Samarium (153SM)
- Keywords
- Samarium, Kyphoplasty, Pain management, Bone metastases, Histologically proven malignancy in the primary site, Radiographic evidence of bone metastasis, Significant pain equal or more than score 5, Karnofsky Performance status >40, The patient must sign a study specific informed consent
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samarium (153SM)Drug
The Samarium is introduced into the vertebral cavity using a 2-way valve by the radiation oncologist. The cement is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon.
| Study group | Role | What they receive |
|---|---|---|
| Samarium (153SM) | Experimental | Injection of Samarium (153SM) Receives: Drug: Samarium (153SM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of intravertebral injection of Samarium on the relief of pain
Measuring the pain by the Visual Analogue Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hani Ashamalla, MD, New York Presbyterian Brooklyn Methodist Hospital
- Investigators
- Hani Ashamalla, MD, FCCP, Principal investigator, New York Presbyterian Brooklyn Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374751
- Sponsor's protocol ID
- NYM-354
- Status last verified
- Aug 2019
- First submitted
- 8 Sep 2006
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of the Use of Vertebral Intracavitary Cement and Samarium (VICS) for Painful Vertebral Metastases
- ClinicalTrials.gov ID
- NCT00374751
- Acronym / sponsor ID
- NYM-354
- Conditions
- Cancer, Metastasis, Pain
- Keywords
- Samarium, Kyphoplasty, Pain management, Bone metastases, Histologically proven malignancy in the primary site, Radiographic evidence of bone metastasis, Significant pain equal or more than score 5, Karnofsky Performance status >40
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- New York Presbyterian Brooklyn Methodist HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the induced cavity with a cement like substance.
The investigators are studying the effects (good or bad) of adding samarium (a radioactive substance) to the cement that is injected into the induced cavity.
Detailed description
Protocol:
- Patients with bone metastases will be identified and discussed in the weekly joint Neuroscience meeting held in Radiation Oncology Department.
- If the patient is eligible to this study, the protocol will be offered to him/her. If the patient accepts; informed consent will be obtained.
- The case will be scheduled jointly by Neurosurgeon and Radiation Oncologist.
- Radiation physicist orders the radioactive samarium.
During the procedure:
- Neurosurgical procedure ( kyphoplasty/vertebroplasty) is performed as standard using . mild general sedation and local anesthesia.
- Once a cavity is identified in fluoroscopy, the trocar is secured. The volume and pressure of the kyphoplasty balloon are recorded.
- According to standard practice; only the radiation team (Radiation oncologist, Physicist) is handling the radioactive material. All work is done under sterile conditions.
- Two mCi. of Samarium is prepared after serial dilution steps under radiation precautions in the department of radiation oncology and material is transferred to OR.
- 0.5ml of "Head Cement" is administered first to act as a seal.
- The Samarium is then introduced into the vertebral cavity using a 2-way valve by the Radiation Oncologist. Total of 0.5ml (Samarium+0.2ml radio opaque material)
- The "Foot cement" (0.5 ml) is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon to flush any remains of radioactivity in the system.
- The two way valve is then removed and the rest of kyphoplasty/vertebroplasty is ensued as per their ordinary protocol.
- Final volume of cement injected is recorded.
- After securing the wound, all devices, syringes, gloves and basins used for handling the radioactive substance are collected in a "red bag" and stored by radiation safety officer in the hot lab. till full radioactive decay.
- The room is scanned after patient's discharge, any spillage should be reported to radiation safety officer and normal procedures for environmental protection are ensued.
Post Procedure:
- Normal neurosurgical recovery room protocol is employed. No radiation precautions needed.
- Patient can be discharged home. No delays because of radiation precautions
- Once patient is cleared, a nuclear imaging scan is obtained with Gamma camera. The ratio of uptake in the vertebra to background is calculated. Moreover, Full body scan is obtained to identify other areas of uptake if any.
- A second nuclear imaging scan is done on the 4th day of the procedure (Two half Lives) to document significant decay and calculate dose.
- MRI/CT scan of the area treated should be done in 4 weeks to assess outcome.
- Clinical follow up is obtained at 2, 4 weeks and in 3 months. Careful pain score assessment is included in each time (Use Study Flow Sheet)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Samarium (153SM) | Experimental | Drug: Samarium (153SM)Injection of Samarium (153SM) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient must be 18 years of age or older
- The patient must have histologically proven malignancy in the primary site (breast, prostate, or lung)
- The patient must have a radiographic evidence of bone metastasis, and this must have been performed within 8 weeks prior to enrollment in the study. Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans, magnetic resonance imaging, and PET-CT scans.
- The patient must have an intact anterior wall of spinal canal
- The patient must have significant pain (score 6 or above,)which appears to be related to the radiographically documented metastatic vertebra(e) in concern, as measured by the "Visual Analog Scale"
Key exclusion criteria (4 listed)
- Epidural soft tissue component
- Patients with vertebral metastases and with clinical or radiographic evidence of spinal cord or cauda equina impingement (effacement) or compression
- Inability to undergo anesthesia
- Hematologic primary malignancies Patients received systemic radiotherapy (89SR or 153SM)within 30 days prior to enrollmen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Samarium (153SM)The Samarium is introduced into the vertebral cavity using a 2-way valve by the radiation oncologist. The cement is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon. | Drug | Samarium (153SM) |
Primary outcome
To determine the effect of intravertebral injection of Samarium on the relief of pain
Time frame: 6 months
Measuring the pain by the Visual Analogue Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hani Ashamalla, MD, FCCP principal investigator
New York Presbyterian Brooklyn Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Samarium (153SM) in people with Cancer and Metastasis, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effect of intravertebral injection of Samarium on the relief of pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.