A Pilot Study Assessing the Feasibility and Safety of Measuring Interstitial Fluid Pressure (IFP) in Patients With Advanced Malignant Melanoma Before Starting Systemic Treatment
Tumor Pressure Testing:
If you are found to be eligible to take part in this study, the pressure in up to three
tumors will be measured. Medical photography will also be used for documentation if needed.
This will be done in the melanoma outpatient clinic. You will be asked to lie down and the
skin over the lesion will be cleaned with betadine (iodine) or a different cleaning agent if
you are allergic to iodine. The skin over the lesion will then be numbed with anesthetic.
A topical anesthetic is a local anesthetic that is used to numb the surface of a body part.
Thirty minutes before the IFP measurement, an EMLA patch (Lidocaine 2.5% and Prilocaine
2.5%) will be applied on the surface of study. Your treating doctor may prescribe a pain
drug to help with any discomfort the measurement may cause.
For the tumor measurement, the tip of a needle will be inserted in a skin lesion (similar to
a biopsy needle). The needle is connected to a machine that reads the pressure inside the
tumor. The measurement itself will take a few seconds. The whole process, including cleaning
and numbing the lesion, will take about 3-4 minutes.
You will stay in the clinic and be monitored for side effects for about 1 hour following the
At 3 days after the measurement, you will be asked if you have experienced any side effects.
If you are not coming to the clinic, you will be called.
Length of Study:
You will be off study after you have completed two cycles of chemotherapy and the second set
of tumor measurements are done.
After the 2 cycles of chemotherapy, you will be checked for tumor response. The IFP study
will be finished at this time. You will also receive a phone call 30 days after the
procedure to see if you have experienced any side effects.
This is an investigational study. Measuring tumor pressure before chemotherapy is
Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility measured by proportion of patients in whom interstitial fluid pressure (IFP) can be measured
Baseline only + follow up 3 days after measurement
Jade Homsi, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration