Completed

buffering SLNDoes Alkalinization of Technetium-99m Sulfur Colloid Reduce Perceived Pain Levels During Non-breast Sentinel Lymphoscintigraphy?

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What is being tested

ph Altered first

+ Standard of Care First

Drug
Who is being recruted

Neurologic Manifestations+1

+ Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

From 18 to 122 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorUniversity of Arkansas
Last updated: November 20, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

Pain during nuclear medicine breast lymphnode detection procedures has been reported as high as 8.8/10. Using Sodium Bicarbonate to alkalinize the radio-pharmaceutical injection, pain can safely be reduced from 6.6/10 to 4.7/10, during breast lymph node detection procedures. In sites other then the breast, using Bicarbonate to make the injection's pH closer to natural, attempts to lower the pain levels will be performed. Hypothesis: The perceived pain level during non breast sentinel lymph node techniques can be reduced by raising the pH of the injectate (Tc-99m SC) to near the physiologic level of pH 7.40.

NCT01660412
Principal SponsorUniversity of Arkansas
Last updated: November 20, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 122 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Criteria

2 inclusion criteria required to participate
Patients presenting for SLN imaging for melanoma or who have had an excisional biopsy for melanoma of the thorax and appendicular structures
Patients scheduled to receive two or more injections of Tc-99m SC for the purpose of clinical management of melanoma or who have had an excisional biopsy for melanoma of the thorax and appendicular structures
3 exclusion criteria prevent from participating
Patients presenting for SLN imaging of lesions involving the breast, ear, nose, and genitourinary regions
Patients scheduled to receive only a single injection of Tc-99m SC
Pregnant or breast feeding women

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered.

Group II

Active Comparator
The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

UAMS

Little Rock, United StatesOpen UAMS in Google Maps
CompletedOne Study Center