None listed
Conditions
Interventions
Laser treatment Type of group
All patients will receive 200 ul at 5000 ul of 0.25% ICG depending on the size of the tumor, laser treatment will be applied locally. The laser parameters will be set at 3 watts and 10 minutes, immediately after the laser treatment will be injected, between 1000 pl and 5000 pl of GC in the tumor and around it.
Sponsors
IMMUNOPHOTONICS / THE SOURCE SAC,
Eligibility
Sex/Gender
Female
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Be over 20 years old and under 80. • Have clinical cycles of recurrent breast cancer • Have no other therapeutic options at hand. • Be considered able to return for all study visits for one year
Exclusion criteria
Exclusion criteria: • Have another systemic disease that compromises the tumor being studied. • Be receiving or having received in a period of 4 weeks before the start of the study treatment any new drug under investigation: cytokine or systemic steroid therapy. • Be allergic to shellfish • Have cardiovascular disease of class III or IV according to the functional criteria of the association of cardiac studies in New York. • Currently, have samples of the history of liver disease, kidney disease, allergic rheumatology (i.e. anaphylactic reaction) or CMS (including seizures) • Have Diabetes Melitus. • Have signs or history of clinical depression or suicidal tendencies. • Have autoimmune thyroid disease or Systemic Lupus Erythematosus • Having skin of type 5 or 6 in the area to be treated (laser light cannot penetrate skin that is very dark enough). • Have a tattoo that covers the area to be treated (the laser light cannot penetrate the tattoos well enough).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:based on the physical and radiographic measurement of the tumor at the end of 52 weeks of treatment or earlier if treatment is discontinued prematurely. Measure:Response rate Timepoints:52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of hematology laboratory test values during the study Measure:Variation in the values of hematology studies Timepoints:after 2, 6, 12, 24 and 36 weeks of treatment | — |
Contacts
Public ContactGabriela Luz Ferrel
IMMUNOPHOTONICS,INC.-THE SOURCE SAC
Outcome results
None listed