Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06223659
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2024-01-02
Brief Title:
EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Investigating the Use of EMLA Topical Cream for Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Cutaneous Cancers
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests how well EMLA topical cream works in treating pain in patients with skin cancers receiving Technetium 99 injections for a lymphoscintigraphy mapping procedure A lymphoscintigraphy mapping procedure is used to find the main or lead lymph node tissue that fight infection so it can be removed and checked for tumor cells Using lymphoscintigraphy to highlight and then surgically remove lymph nodes is standard way to treat skin cancer for many patients The Technetium 99 injections used for lymphoscintigraphy can be briefly painful due to the sensitivity of the nerve endings in the skin The EMLA topical cream which contains a numbing medicine to block pain from nerve endings has been studied in breast cancer patients with a difference in pain reported but this is the first time it has been studied in patients undergoing lymphoscintigraphy for skin cancer This study may help researchers learn whether the use of EMLA cream may improve the associated pain at the time of the lymphoscintigraphy procedure
Detailed Description:
PRIMARY OBJECTIVE
I Evaluate if the application of eutectic mixture of local anesthetics EMLA topical cream 25 lidocaine mixed with 25 prilocaine prior to intra-dermal Technetium 99 sulfur colloid Tc99 injection for lymphoscintigraphy can improve associated pain
OUTLINE Patients are randomized to 1 of 2 cohorts
COHORT 1 Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure
COHORT 2 Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure
I Evaluate if the application of eutectic mixture of local anesthetics EMLA topical cream 25 lidocaine mixed with 25 prilocaine prior to intra-dermal Technetium 99 sulfur colloid Tc99 injection for lymphoscintigraphy can improve associated pain
OUTLINE Patients are randomized to 1 of 2 cohorts
COHORT 1 Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure
COHORT 2 Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-10465 | REGISTRY | CTRP Clinical Trial Reporting Program | None |