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

NCT07707024 | Not Yet Recruiting DMC

• 3 other identifiers: 25826NCI-2026-04599P30CA033572
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bone Neoplasm; Metastatic Malignant Neoplasm in the Bone

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline, Up to 1 year

Secondary Outcomes (14)

• Distribution of BCR reflex parameters

  From baseline, Up to 1 year

• Distribution of EUS reflex parameters

  From baseline, Up to 1 year

• Change in BCR reflex parameters

  From baseline, Up to 1 year

• Change in EUS reflex parameters

  From baseline, Up to 1 year

• Relative contribution of individual right sacral nerve roots to BCR amplitude

  During intraoperative stimulation, Up to Day 21

Study Arms (1)

Diagnostic (Intraoperative neuromonitoring)

EXPERIMENTAL

Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.

Procedure: Intraoperative Nerve Monitoring; Procedure: Surgical Procedure; Other: Survey Administration

Interventions

Intraoperative Nerve Monitoring PROCEDURE

Undergo intraoperative neuromonitoring

Also known as: Intraoperative Neuromonitoring, Intraoperative Neurophysiological Monitoring, IONM

Diagnostic (Intraoperative neuromonitoring)

Surgical Procedure PROCEDURE

Undergo standard of care surgery

Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Diagnostic (Intraoperative neuromonitoring)

Survey Administration OTHER

Ancillary studies

Diagnostic (Intraoperative neuromonitoring)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Intraoperative Neurophysiological Monitoring; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Intraoperative; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Neurophysiological Monitoring

Study Officials

• Alana M Munger

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): January 10, 2027
• Primary Completion (Estimated): June 10, 2029
• Study Completion (Estimated): June 10, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

US (1)