Pandora wrote: Oilminerdeluxe wrote: Hm, did the first 3 already treated for the 2nd time get the new optimized treatment? Perhaps not important in the long run if we can start a new batch of patients with the right dosage and light. i wish Lilge would zapp everyone participating.
Just an attempt to put the info from the newsletter in a little different format:
Of the 8 patients eligible to receive the second treatment in Study II, three patients have received their second treatment. These patients had "CR" results i.e. no evidence of cancer in their bladders -and- no evidence of carcinoma cells in their urine.
Note: I had a little problem with clearly understanding the next steps. The newsletter first suggests 4 patients are under review for "suspicious" results and then in the next breath they say they are awaiting second treatment solely based on OR availability. I will assume one follows the other and maybe the "review" is already complete.
Four other patients are awaiting the second treatment, subject to clinical study site operating room availability. Also one patient (#8) is undergoing additional assessments prior to proceeding to second treatment.
The first three of these four other patients who "responded" ('R') to the Study Treatment had a suspicious "cytology". This suggests evidence of carcinoma cells in their urine. They are currently under medical review to assess the cause and this will be done by repeating the urine cytology analysis.
The fourth had a suspicious "cystoscopy" which indicates possible evidence of cancer in their bladder. This will require a biopsy of the bladder.
Following is just extra reading on definitions, terminology, etc. for anyone who might be interested: Cystoscopy
A "cystoscopy" is performed using a cystoscope, a thin tube with a small camera on the end. The procedure takes between 10 and 20 minutes.
Because the urine from your first morning urination remains in your bladder for many hours through the night, the cells may degrade and not be useful for "urine cytology". However, this doesn’t mean you should urinate right before the test. In fact, you may need to hold urine in your bladder for a few hours prior to a cystoscopy. Be sure to ask your doctor for specific instructions before the test.
For a cystoscopy, your doctor will clean the skin around your urethra (the tube coming out from the bladder) and use a topical gel to numb the area. They will insert the cystoscope into your urethra and up into your bladder. You may feel some pressure and an urge to urinate. Your doctor will drain your urine into a sterile container, and then remove the catheter.
The procedure carries a small risk of infection or bleeding. Your doctor will send the urine sample to a laboratory for analysis, and then will receive a report.
"Cytology" is the examination of cells from the body under a microscope. In a urine cytology exam, a doctor looks at cells collected from a urine specimen to see how they look and function. The test commonly checks for infection, inflammatory disease of the urinary tract, cancer, or precancerous conditions.
This procedure is different from a biopsy in that it examines individual cells, rather than pieces of tissue containing many cell clusters. The cells for urine cytology are easier to obtain than tissue, causing less discomfort and less risk to the patient. Sometimes a biopsy is necessary after abnormal results from urine cytology to clarify a diagnosis.
The accuracy of urine cytology depends on several factors that are mainly related to tumor grade, the nature of specimen, and sampling. It has long been known that urine cytology is accurate in the diagnosis of high-grade urothelial carcinoma (HGUCA) with cytohistologic correlation reported as high as 98%.
Negative results of cytology mean that no abnormal cells were found. A positive result means that abnormal cells were found and that you may have a problem in your urinary tract.
Different laboratories use different language in their reports. Your doctor will be able to explain what your results mean. There are some common terms that can describe your results.
Negative
If your urine cells appear normal and are free of bacteria and yeast, this is a normal result. Most labs will call this a “negative” result.
Unsatisfactory
The lab may label your specimen “unsatisfactory” if there weren’t enough usable cells in the sample. In this case, you will likely have to repeat the procedure and provide a new sample.
Atypical or suspicious
These terms describe when cells don’t appear normal, but it can’t be confirmed that they are cancerous or precancerous.
Positive
If bacteria or yeast are present in the culture, you probably have a bladder or urinary tract infection. Antibiotics can usually treat these conditions.
Cells that appear abnormal in your urine may also indicate inflammation in the urinary tract or cancer of the bladder, kidney, ureter, or urethra.
However, an abnormal urine cytology result can’t diagnose these diseases. Additional tests are usually necessary to confirm the diagnosis.
If found to be negative, these patients will be allocated to the 'CR' column.
If positive or suspicious again, then Computerized Tomography (“CT”) Scan imaging and/or prostatic biopsies will be conducted to rule out Upper Tract Urothelial Cell Carcinoma (“UTUCC”).
If UTUCC is proven to exist, then according to FDA’s Bacillus Calmete Gurin (“BCG”)-Unresponsive Guidelines to Industry, issued in February 2018, these patients will be classified as "CR", as only the bladder was treated by the Study Treatment and not the non-addressable areas of the urinary system.
So 3 out of 8 were considered "CR" and have already received their second treatment.
Another 3 out of 8 had a 'suspicious' cytology