Clinical trial · Interventional
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
NCT01003626CI-TRIAL-00006317withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transducer-catheter SPC-320 + Amplifier | Device | — | UNRESOLVED |
| Tumor Interstitial Fluid Pressure (IFP) assessments | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IFP Measurement
- description
- Tumor interstitial fluid pressure (IFP) assessments
- interventionNames
- Procedure: Tumor Interstitial Fluid Pressure (IFP) assessments
- Device: Transducer-catheter SPC-320 + Amplifier
Primary outcomes (1)
- measure
- Feasibility measured by proportion of patients in whom interstitial fluid pressure (IFP) can be measured
- timeFrame
- Baseline only + follow up 3 days after measurement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologic confirmation of malignant melanoma and skin lesion, and/or subcutaneous metastases. 2. Males and Females \>/= 18 years of age. 3. Subject is willing and able to comply with scheduled visits and other trial procedures. 4. Patients must be chemo-naive for malignant melanoma. Prior immunotherapy is allowed. 5. Must be scheduled for systemic chemotherapy within 3 weeks of measurements 6. Patient must have at least a one intact tumor or satellite lesion measuring \>/= 10 mm in longest diameter. 7. Patients must sign and date an informed consent. Exclusion Criteria: 1. Major surgery or radiation therapy close to the area where tumor IPF will be measured, within 4 weeks of starting the study treatment. 2. Patients with the only melanoma skin lesions being localized in the area of the head and neck. 3. High risk of bleeding with platelets \</= 50,000 microliter, Partial thromboplastin time (PTT)/prothrombin time (PT) \> 2 times upper limit of normal or patients on any type of anticoagulation. 4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and in the judgment of the investigator or his designee would make the subject inappropriate for entry into this study. 5. Patients will be excluded if they are receiving biological agents only. 6. Pregnant or lactating females.
References
Publications (0)
Data not yet available
No reference posted for this study.