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NCT00940199 · ClinicalTrials.gov registry record

PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial

A clinical trial of Breast Cancer, sponsored by Walter Reed Army Medical Center.

Completed
Registry status
140
Enrollment target
1
Study location

NCT00940199 is a study of Breast Cancer that has completed, run by Walter Reed Army Medical Center. The registered enrollment target is 140 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00940199, a study of Breast Cancer, has completed, sponsored by Walter Reed Army Medical Center.

COMPLETED
Registry status
140 participants
Enrollment target
1
Study location

Study Summary

Patients with breast cancer scheduled to undergo sentinel lymph node mapping and biopsy will be randomly assigned to one of four treatment groups: I: (Standard of Care at WRAMC): Application of L-M-X topical anesthetic cream 4% to the breast within one hour of sub-areaolar injection of 4 ml 99mTc-sulfur colloid (1 mCi in normal saline) II. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate) III. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in 1% Lidocaine) IV. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate + 1% Lidocaine) The primary study outcome is pain, which will be evaluated for each study group before, and after radiocolloid injection utilizing a standardized 10-point Likert scale, the Wong-Baker FACES Pain Rating Scale, and the McGill Pain Questionnaire. Physician appraisal of patient pain (Wong-Baker FACES Pain Rating Scale) will be estimated during the radiocolloid injection and compared with that of the patient.

Conditions Studied

Study Locations (1)

District of Columbia

  • Walter Reed Army Medical Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2006-08
Est. Completion 2009-06

Sponsor

Walter Reed Army Medical Center

24 total trials

What the Registry Record Tells You About NCT00940199

The ClinicalTrials.gov registry entry for NCT00940199 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Walter Reed Army Medical Center, which has 24 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 0 interventions.

NCT00940199 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.

Frequently Asked Questions

What is clinical trial NCT00940199 about?

NCT00940199 is a clinical study titled "PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial". Patients with breast cancer scheduled to undergo sentinel lymph node mapping and biopsy will be randomly assigned to one of four treatment groups: I: (Standard of Care at WRAMC): Application of L-M-X topical anesthetic cream 4% to the breast within one hour of sub-areaolar injection of 4 ml 99mTc-s...

What is the current status of trial NCT00940199?

This trial is currently completed. The enrollment target is 140 participants. The study started on 2006-08. Estimated completion is 2009-06.

What conditions does trial NCT00940199 study?

This clinical trial studies the following conditions: Breast Cancer.

Who is sponsoring clinical trial NCT00940199?

This trial is sponsored by Walter Reed Army Medical Center, which has 24 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00940199 being conducted?

This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.