Prospective Paired Evaluation of Conventional Versus Structured Magnetic Resonance Imaging Interpretation for Preoperative Assessment of Gluteal Permanent Synthetic Filler Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorResearch Inc

About this trial

This prospective paired diagnostic-impact study will compare conventional qualitative MRI reporting with a new structured anatomic classification in adults undergoing surgery for gluteal permanent synthetic filler disease. The structured report will document material effects across superficial, deep, muscular, regional, lymphatic, and interstitial compartments. Standardized intraoperative mapping will serve as the reference standard. The main outcome is the difference in sensitivity for surgically confirmed compartment involvement

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

History of gluteal injection with a permanent or unknown nonresorbable filler.

Preoperative pelvic/gluteal MRI performed using the study acquisition protocol.

Planned surgical removal, biopsy, or operative exploration within 90 days after MRI.

Disqualifiers

MRI contraindication or nondiagnostic imaging caused by motion or incomplete anatomic coverage.

Prior extensive gluteal filler removal that prevents mapping of the predefined compartments.

No operative procedure within 90 days after MRI and therefore no reference-standard assessment.

Acute life-threatening infection or emergency surgery that prevents completion of the preoperative reporting sequence.

Trial population

Adults with prior gluteal injection of permanent synthetic fillers who undergo preoperative pelvic/gluteal MRI and are scheduled for surgical removal or exploration.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Conventional Qualitative MRI Interpretation

    Diagnostic test

    The report records the presence or absence of injected foreign material in the gluteal region and any routinely reported findings. A preliminary surgical plan is recorded after review of this report. Linked arm/group(s): Paired MRI Interpretation Cohort.

  • Structured Gluteal Filler MRI Classification

    Diagnostic test

    The report records material distribution and severity in predefined compartments: fat-fascia interface, subcutaneous fat, deep fascia, gluteal muscles, subcrestal region, ischial region, trochanteric region, pelvic ring, lymphatic pathways, and interstitial involvement. The final classification manual and grade definitions will be locked before enrollment. Linked arm/group(s): Paired MRI Interpretation Cohort.

  • Standardized Intraoperative Anatomic Mapping

    Procedure/Surgery

    During the index operation, the surgeon documents actual involvement of each predefined compartment before reviewing the imaging accuracy analysis. Operative photographs, specimen mapping, and histopathology may support the reference standard. Linked arm/group(s): Paired MRI Interpretation Cohort.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Paired MRI Interpretation Cohort3 interventions

Trial outcomes

Primary outcomes

1

Sensitivity for Surgically Confirmed Anatomic Compartment Involvement

For each reporting method, sensitivity is the number of predefined compartments identified as involved on MRI divided by the number confirmed as involved during standardized intraoperative mapping. The structured and conventional results will be compared within the same participant.

Time frame
Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 days

Secondary outcomes

1

Specificity for Surgically Uninvolved Anatomic Compartments

For each method, specificity is the number of compartments correctly identified as uninvolved on MRI divided by the number documented as uninvolved at surgery.

Time frame
Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 dys
2

Change in Preoperative Surgical Plan After Structured MRI Review

Proportion of participants for whom the recorded operative plan changes after the structured report, including planned incision, extent of excision, anticipated deep-plane dissection, lymphatic evaluation, or reconstruction strategy.

Time frame
Immediately after the conventional report and immediately after the structured report, both before surgery. 1 day
3

Surgeon-Rated MRI Report Utility

The operating surgeon rates completeness, anatomic clarity, confidence, and usefulness for planning on prespecified 0-to-10 scales after each report. Higher scores indicate greater perceived utility.

Time frame
Immediately after review of each preoperative MRI report. 1 day

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: