Melanoma Clinical Trial
Official title:
A Phase II Study of High-resolution Contrast-enhanced MRI of Regional Lymph Nodes in Patients With Clinically Localized Invasive Melanoma
The study is designed to see if a high-resolution MRI scan of lymph node areas near where a melanoma has been removed from the skin can pick up the spread of melanoma to those lymph nodes with a high degree of accuracy.
When a melanoma of the skin is diagnosed, there is some chance it can spread to nearby lymph
nodes, and from there to other parts of the body. Currently, patients with melanoma at low
risk for spreading to lymph nodes do not get the lymph nodes assessed except by a physical
exam. Those at high risk for spreading to lymph nodes get one or more lymph nodes removed
surgically to check for melanoma spread. But physical exam alone will often miss small areas
of melanoma in lymph nodes; removal of lymph nodes by surgery is painful and can cause
complications. Neither assessment tool is optimal.
This study is designed to see if use of very high-resolution contrast-enhanced MRI scans of
lymph node areas near the primary melanoma site in the skin can accurately detect small
areas of melanoma spread to those lymph nodes. If this turns out to be the case, in the
future, MRI scans could potentially be an alternative for assessing lymph nodes, compared to
physical exams alone or surgical removal of the lymph nodes.
In this study, patients with low risk melanoma will receive very high-resolution MRI scans
of nearby lymph nodes every 6 months for 5 years of follow-up. If the MRI looks abnormal,
the lymph nodes will be biopsied, and results from the biopsy compared to the results from
the MRI.
Patients with high risk melanoma will get a baseline MRI of the nearby lymph nodes, and then
one or more lymph nodes will be removed (usually by sentinel lymph node biopsy) regardless
of the MRI results. Again, results from the biopsy will be compared to the results from the
MRI. MRI's will still be repeated every 6 months to assess whether lymph nodes not removed
at surgery develop any changes.
We plan to enroll 200 patients on this study and by the end of the study will have a measure
of the sensitivity and specificity of high-resolution MRI scans in the detection of melanoma
involvement of regional lymph nodes.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Completed |
NCT03979872 -
Risk Information and Skin-cancer Education for Undergraduate Prevention
|
N/A | |
| Recruiting |
NCT04986748 -
Using QPOP to Predict Treatment for Sarcomas and Melanomas
|
||
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Recruiting |
NCT05707286 -
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
|
||
| Active, not recruiting |
NCT05470283 -
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
|
Phase 1 | |
| Recruiting |
NCT05077137 -
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
|
Phase 1 | |
| Active, not recruiting |
NCT02721459 -
XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma
|
Phase 1 | |
| Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
| Recruiting |
NCT05839912 -
Excision of Lymph Node Trial (EXCILYNT) (Mel69)
|
N/A | |
| Recruiting |
NCT04971499 -
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05263453 -
HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation
|
Phase 2 | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06413680 -
A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT03348891 -
TNF in Melanoma Patients Treated With Immunotherapy
|
N/A | |
| Terminated |
NCT03399448 -
NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)
|
Phase 1 | |
| Completed |
NCT03171064 -
Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment
|
Phase 2 | |
| Not yet recruiting |
NCT05539118 -
Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05171374 -
pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
|
||
| Withdrawn |
NCT02854488 -
Yervoy Pregnancy Surveillance Study
|