Bone NeoplasmNCT07707024
Intraoperative Neuromonitoring of Sacral Reflexes to Predict Post Operative Function in Patients Undergoing Sacrectomy for Pelvic Bone Malignancy or Patients Undergoing Spinal Procedures Without Sacral Root Involvement
A study testing Intraoperative Nerve Monitoring, Surgical Procedure and Survey Administration in people with Bone Neoplasm and Metastatic Malignant Neoplasm in the Bone, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This clinical trial tests how well monitoring the sacral reflexes during surgery (intraoperatively) works to predict the post operative function for patients undergoing removal of the lowest part of the spine (sacrectomy) for pelvic bone cancers or patients undergoing spinal procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Neoplasm, Metastatic Malignant Neoplasm in the Bone
- What is being tested?
- Intraoperative Nerve Monitoring, Surgical Procedure and Survey Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2027to 10 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines
- Age: ≥ 18 years
- Ability to complete study questionnaires
- Willingness to comply with all study procedures, including postoperative patient-reported outcome (PRO) assessments
- Undergoing surgery at City of Hope involving either:
- Complete or partial sacrectomy for primary or metastatic bone tumors, or
- Thoracolumbar intervention in which the sacral roots are not exposed or manipulated (reference cohort)
Who cannot join
- Prior sacrectomy or prior surgery resulting in complete sacral nerve transection
- For thoracolumbar cohort patients, prior diagnosis or patient report of bowel or bladder dysfunction
- Cognitive or psychiatric conditions preventing reliable completion of PRO instruments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
Alana M. Munger, 808-384-0975, amunger@coh.org
Alana M. Munger
About this study
Official title: Phase 2a Prospective Study of Intraoperative Neuromonitoring of the Bulbocavernosus and External Urethral Sphincter Reflexes
This clinical trial tests how well monitoring the sacral reflexes during surgery (intraoperatively) works to predict the post operative function for patients undergoing removal of the lowest part of the spine (sacrectomy) for pelvic bone cancers or patients undergoing spinal procedures. These surgical procedures can lead to damage to sacral root nerves which can result in impairment to the lower extremities, bowel, bladder, and sexual function. Intraoperative monitoring of sacral reflexes can provide objective, real-time information about pelvic nerve function during surgery. This can aid surgical decision-making and help surgeons better prepare patients to understand the changes that may have occurred to their function as a result of surgery. Intraoperative neuromonitoring may work well to predict postoperative function in patients undergoing sacrectomy for pelvic bone malignancy or patients undergoing spinal procedures.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility of acquiring analyzable sacral reflex neuromonitoring data at baseline and case closure during surgery.
SECONDARY OBJECTIVES:
- To characterize sacral reflex parameters amplitude, latency, waveform morphology, and Nerveana Power Index (NPI) at baseline under standardized intraoperative neuromonitoring conditions in patients undergoing spinal procedures without sacral nerve root involvement and patients undergoing sacrectomy.
II. To describe intraoperative changes in sacral reflex parameters from baseline to end-of-case during standardized intraoperative neuromonitoring in patients undergoing sacrectomy.
III. To characterize the relative contribution of individual sacral nerve roots to sacral reflex responses during intraoperative stimulation in patients undergoing sacrectomy.
IV. To characterize longitudinal changes in postoperative functional outcomes in patients undergoing sacrectomy.
EXPLORATORY OBJECTIVES:
- To explore the association between intraoperative sacral reflex changes and postoperative functional outcomes in patients undergoing sacrectomy.
II. To explore the association between sacrifice of higher- versus lower-contributing sacral nerve roots and postoperative functional outcomes in patients undergoing sacrectomy.
OUTLINE:
Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.
After completion of study treatment, patients are followed up at 21 days, 6 weeks and 3, 6 and 12 months.
- Being tested
- Intraoperative Nerve Monitoring, Surgical Procedure, Survey Administration
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Nerve MonitoringProcedure or surgery
Also called Intraoperative Neuromonitoring, Intraoperative Neurophysiological Monitoring, IONM
Undergo intraoperative neuromonitoring
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgery, NOS
Undergo standard of care surgery
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (Intraoperative neuromonitoring) | Experimental | Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery. Receives: Procedure: Intraoperative Nerve Monitoring; Procedure: Surgical Procedure; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)
Reproducible is defined as the ability to elicit a reflex response on repeated stimulation with consistent waveform presence and morphology at a given timepoint. Interpretable is defined as a recorded reflex response that is distinguishable from background noise and artifact and permits determination of response presence or absence and measurement of latency and amplitude. A two-sided 95% Clopper-Pearson confidence interval will be provided as a measure of precision.
Measured: From baseline, Up to 1 year
Secondary outcomes (14)
Distribution of BCR reflex parameters
Amplitude, latency, frequency distribution, etc, measured via intraoperative neuromonitoring (IONM). ), Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for BCR for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter.
Measured: From baseline, Up to 1 year
Distribution of EUS reflex parameters
Amplitude, latency, frequency distribution, etc, measured via IONM. Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for EUS for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter.
Measured: From baseline, Up to 1 year
Change in BCR reflex parameters
Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for BCR for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter.
Measured: From baseline, Up to 1 year
Change in EUS reflex parameters
Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for EUS for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter.
Measured: From baseline, Up to 1 year
Relative contribution of individual right sacral nerve roots to BCR amplitude
Amplitudes among sacrectomy patients will be descriptively reported.
Measured: During intraoperative stimulation, Up to Day 21
Relative contribution of individual left sacral nerve roots to BCR amplitude
Amplitudes among sacrectomy patients will be descriptively reported.
Measured: During intraoperative stimulation, Up to Day 21
Relative contribution of individual right sacral nerve roots to EUS amplitude
Amplitudes among sacrectomy patients will be descriptively reported.
Measured: During intraoperative stimulation, Up to Day 21
Relative contribution of individual left sacral nerve roots to EUS amplitude
Amplitudes among sacrectomy patients will be descriptively reported.
Measured: During intraoperative stimulation, Up to Day 21
Bowel function scores
Assessed by Memorial Sloan Kettering Bowel Function Instrument. Will be described by graphs and descriptive statistics at each time point.
Measured: From baseline, Up to 1 year
Bladder function scores
Assessed by International Consultation on Incontinence Questionnaire. Will be described by graphs and descriptive statistics at each time point.
Measured: From baseline, up to 1 year
Sexual function scores
Assessed by Female Sexual Function Index (female patients only) and International Index of Erectile Function (male patients only). Will be described by graphs and descriptive statistics at each time point.
Measured: From baseline, up to 1 year
Lower extremity function
Assessed by Toronto Extremity Salvage Score for the Lower Extremity. Will be described by graphs and descriptive statistics at each time point.
Measured: From baseline, up to 1 year
Quality of life
Assessed by Functional Assessment of Cancer Therapy-General. Will be described by graphs and descriptive statistics at each time point.
Measured: From baseline, up to 1 year
Postoperative urologic function
Assessed by post-void residual (PVR) or cystometry. Will be described by graphs and descriptive statistics at each time point.
Measured: From baseline, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start10 Jan 2027 (estimated)
- Primary completion10 Jun 2029 (estimated)
- Study completion10 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alana M Munger, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707024
- Sponsor's protocol ID
- 25826
- Other IDs
- NCI-2026-04599, 25826, P30CA033572
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Prospective Study of Intraoperative Neuromonitoring of the Bulbocavernosus and External Urethral Sphincter Reflexes
- ClinicalTrials.gov ID
- NCT07707024
- Acronym / sponsor ID
- 25826
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Jan 2027 (estimated)
- Primary completion
- 10 Jun 2029 (estimated)
- Study completion
- 10 Jun 2029 (estimated)
- First posted
- 16 Jul 2026 (actual)
- 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.
This clinical trial tests how well monitoring the sacral reflexes during surgery (intraoperatively) works to predict the post operative function for patients undergoing removal of the lowest part of the spine (sacrectomy) for pelvic bone cancers or patients undergoing spinal procedures. These surgical procedures can lead to damage to sacral root nerves which can result in impairment to the lower extremities, bowel, bladder, and sexual function. Intraoperative monitoring of sacral reflexes can provide objective, real-time information about pelvic nerve function during surgery. This can aid surgical decision-making and help surgeons better prepare patients to understand the changes that may have occurred to their function as a result of surgery. Intraoperative neuromonitoring may work well to predict postoperative function in patients undergoing sacrectomy for pelvic bone malignancy or patients undergoing spinal procedures.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility of acquiring analyzable sacral reflex neuromonitoring data at baseline and case closure during surgery.
SECONDARY OBJECTIVES:
- To characterize sacral reflex parameters amplitude, latency, waveform morphology, and Nerveana Power Index (NPI) at baseline under standardized intraoperative neuromonitoring conditions in patients undergoing spinal procedures without sacral nerve root involvement and patients undergoing sacrectomy.
II. To describe intraoperative changes in sacral reflex parameters from baseline to end-of-case during standardized intraoperative neuromonitoring in patients undergoing sacrectomy.
III. To characterize the relative contribution of individual sacral nerve roots to sacral reflex responses during intraoperative stimulation in patients undergoing sacrectomy.
IV. To characterize longitudinal changes in postoperative functional outcomes in patients undergoing sacrectomy.
EXPLORATORY OBJECTIVES:
- To explore the association between intraoperative sacral reflex changes and postoperative functional outcomes in patients undergoing sacrectomy.
II. To explore the association between sacrifice of higher- versus lower-contributing sacral nerve roots and postoperative functional outcomes in patients undergoing sacrectomy.
OUTLINE:
Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.
After completion of study treatment, patients are followed up at 21 days, 6 weeks and 3, 6 and 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Intraoperative neuromonitoring) | Experimental | Procedure: Intraoperative Nerve Monitoring, Procedure: Surgical Procedure, Other: Survey AdministrationPatients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documented informed consent of the participant and/or legally authorized representative.
- Age: ≥ 18 years
- Ability to complete study questionnaires
- Willingness to comply with all study procedures, including postoperative patient-reported outcome (PRO) assessments
- Undergoing surgery at City of Hope involving either:
Key exclusion criteria (3 listed)
- Prior sacrectomy or prior surgery resulting in complete sacral nerve transection
- For thoracolumbar cohort patients, prior diagnosis or patient report of bowel or bladder dysfunction
- Cognitive or psychiatric conditions preventing reliable completion of PRO instruments
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 |
|---|---|---|
| Intraoperative Nerve MonitoringAlso: Intraoperative Neuromonitoring, Intraoperative Neurophysiological Monitoring, IONMUndergo intraoperative neuromonitoring | Procedure or surgery | Diagnostic (Intraoperative neuromonitoring) |
| Surgical ProcedureAlso: Operation, Surgery, Surgery Type, Surgery, NOSUndergo standard of care surgery | Procedure or surgery | Diagnostic (Intraoperative neuromonitoring) |
| Survey AdministrationAncillary studies | Other | Diagnostic (Intraoperative neuromonitoring) |
Primary outcome
Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)
Time frame: From baseline, Up to 1 year
Reproducible is defined as the ability to elicit a reflex response on repeated stimulation with consistent waveform presence and morphology at a given timepoint. Interpretable is defined as a recorded reflex response that is distinguishable from background noise and artifact and permits determination of response presence or absence and measurement of latency and amplitude. A two-sided 95% Clopper-Pearson confidence interval will be provided as a measure of precision.
14 secondary outcomes
Distribution of BCR reflex parameters
Time frame: From baseline, Up to 1 year
Distribution of EUS reflex parameters
Time frame: From baseline, Up to 1 year
Change in BCR reflex parameters
Time frame: From baseline, Up to 1 year
Change in EUS reflex parameters
Time frame: From baseline, Up to 1 year
Relative contribution of individual right sacral nerve roots to BCR amplitude
Time frame: During intraoperative stimulation, Up to Day 21
Relative contribution of individual left sacral nerve roots to BCR amplitude
Time frame: During intraoperative stimulation, Up to Day 21
Relative contribution of individual right sacral nerve roots to EUS amplitude
Time frame: During intraoperative stimulation, Up to Day 21
Relative contribution of individual left sacral nerve roots to EUS amplitude
Time frame: During intraoperative stimulation, Up to Day 21
Bowel function scores
Time frame: From baseline, Up to 1 year
Bladder function scores
Time frame: From baseline, up to 1 year
Sexual function scores
Time frame: From baseline, up to 1 year
Lower extremity function
Time frame: From baseline, up to 1 year
Quality of life
Time frame: From baseline, up to 1 year
Postoperative urologic function
Time frame: From baseline, up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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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.
Alana M Munger principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Nerve Monitoring, Surgical Procedure and Survey Administration in people with Bone Neoplasm and Metastatic Malignant Neoplasm in the Bone, run by City of Hope Medical Center 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 8 inclusion and 3 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: opening soon, as of the sponsor's last update on 16 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility) (time frame: From baseline, Up to 1 year). 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 16 Jul 2026.