Recruiting

Intraoperative Monitoring

Sponsor:

City of Hope Medical Center

Code:

NCT07707024

Conditions

Bone Neoplasm

Metastatic Malignant Neoplasm in the Bone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intraoperative Nerve Monitoring

Surgical Procedure

Survey Administration

Study Details

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

Study ID

NCT07707024

Start date

Jan 10, 2027

Status verified date

Nov, 2026

Completion date

Jun 10, 2029

Anticipated

Primary completion date

Jun 10, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (Intraoperative neuromonitoring)

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

Interventions

Intraoperative Nerve Monitoring

Undergo intraoperative neuromonitoring

Surgical Procedure

Undergo standard of care surgery

Survey Administration

Ancillary studies

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 ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Alana M. Munger

808-384-0975amunger@coh.org

Principal Investigator:

Alana M. Munger

More Information

Sponsor

City of Hope Medical Center

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.