Trial · NCT01965002
Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors
NCT01965002, Not applicable, Terminated, Pejman Ghanouni; results first posted 2018-05-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors. Trials, record NCT01965002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01965002
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors
- NCT number
- NCT01965002
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 5 participants, actual
- Lead sponsor
- Pejman Ghanouni
- Conditions
- Soft Tissue Neoplasms
- Interventions
- MRgHIFU, Aspirin, Enoxaparin
- First posted
- 2013-10-17
- Last updated
- 2018-05-23
- Results first posted
- 2018-05-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Safety - Incidence of Any Device-related Adverse Events | 1 week | Safety determined by evaluating for the incidence of any device-related adverse events. Patients will be assessed for pain and limb function, and by clinical examination before and after treatment to collect adverse events related to the treatment. Safety is reported as the total incidence of device-related adverse events. |
| Secondary | Adverse Event Severity | 6 months | Safety is further assessed by an evaluation of severity for the treatment-related adverse events, reported as the number of adverse events for each of the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grades. CTCAE Severity: 1. mild 2. moderate 3. severe 4. life-threatening 5. fatal |
| Secondary | Percent Successful Tumor Ablation | Up to 1 week | In the resected tumor specimen, the volume of the ablated area will be determined by obtaining a digital photograph of each pathology slice. The region of interest corresponding to the ablated area will be traced, and the ablated area will be calculated for each slice and summed. Accuracy is assessed as the percent ablated volume relative to pre-treatment tumor volume. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Safety - Incidence of Any Device-related Adverse Events | 1 week | All participants were evaluated for adverse events. | device-related adverse events | NUMBER |
| SECONDARY | Adverse Event Severity | 6 months | Treatment-related adverse events | NUMBER | |
| SECONDARY | Percent Successful Tumor Ablation | Up to 1 week | Due to the complexity of 3-dimensional mapping of tumors in soft tissues, the precision necessary to capture baseline tumor volume exceeded the capability of the equipment. Baseline data per protocol for the outcome calculation was only obtained from a single participant, resulting in an inability to conduct a robust per protocol analysis. | percent ablated volume | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Safety - Incidence of Any Device-related Adverse Events | MRgHIFU | 8 | device-related adverse events | ||
| Adverse Event Severity | MRgHIFU | CTCAE Grade 1 | 8 | Treatment-related adverse events | |
| Adverse Event Severity | MRgHIFU | CTCAE Grade 2 | 0 | Treatment-related adverse events | |
| Adverse Event Severity | MRgHIFU | CTCAE Grade 3 | 0 | Treatment-related adverse events | |
| Adverse Event Severity | MRgHIFU | CTCAE Grade 4 | 0 | Treatment-related adverse events | |
| Adverse Event Severity | MRgHIFU | CTCAE Grade 5 | 0 | Treatment-related adverse events | |
| Percent Successful Tumor Ablation | MRgHIFU | 40 | percent ablated volume |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MRgHIFU | 5 | |
| Overall Study | COMPLETED | MRgHIFU | 5 | |
| Overall Study | NOT COMPLETED | MRgHIFU | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain at tumor site | General disorders | MRgHIFU | 1 | 5 | 1 |
| other | Edema at right distal thigh | Skin and subcutaneous tissue disorders | MRgHIFU | 1 | 5 | 1 |
| other | Mild backache from positioning | Musculoskeletal and connective tissue disorders | MRgHIFU | 1 | 5 | 1 |
| other | Diminished sensation along medial thigh | Musculoskeletal and connective tissue disorders | MRgHIFU | 1 | 5 | 1 |
| other | Mild erythema | Skin and subcutaneous tissue disorders | MRgHIFU | 1 | 5 | 1 |
| other | Slight numbness along distal aspect of the incision | Musculoskeletal and connective tissue disorders | MRgHIFU | 1 | 5 | 1 |
| other | Mild pain at tumor site | Musculoskeletal and connective tissue disorders | MRgHIFU | 1 | 5 | 1 |
| other | Reduced range of motion in right knee | Musculoskeletal and connective tissue disorders | MRgHIFU | 1 | 5 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MRgHIFU | 0 | 5 |
| Total, other adverse events | MRgHIFU | 4 | 5 |
| Total, serious adverse events | MRgHIFU | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01965002
GET https://conductscience.org/api/trials/v1/NCT01965002/registered