NCT01003626

Interstitial Fluid Pressure (IFP) Pilot Study in Melanoma Patients

A Pilot Study Assessing the Feasibility and Safety of Measuring Interstitial Fluid Pressure (IFP) in Patients With Advanced Malignant Melanoma Before Starting Systemic Treatment

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn about the side effects of measuring the tumor pressure in patients who have advanced melanoma and have not received chemotherapy. Researchers also want to learn if patients with a lower tumor pressure may respond better to chemotherapy.

Detailed description

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 tumor measurement. 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. Follow-Up: 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 investigational. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

Conditions

• Advanced Cancers
• Melanoma

Interventions

Type	Name	Description
PROCEDURE	Tumor Interstitial Fluid Pressure (IFP) assessments	The tip of a needle will be inserted in a skin lesion (similar to a biopsy needle) for up to 3 tumors. The needle is connected to a machine that reads the pressure inside the tumor. The whole process, including cleaning and numbing the lesion, will take about 3-4 minutes.
DEVICE	Transducer-catheter SPC-320 + Amplifier	Transducer-tipped catheter Mikro-Tip SPC-320 and transducer Millar with Power Lab used to assess the interstitial fluid pressure in a malignant melanona nodule

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-10-29
• Last updated: 2012-02-22