Clinical trial: NCT00026793
Section: Alternatives
Subsections: Alternative Approaches Or Treatments

The imaging techniques have no therapeutic role. These techniques are being studied to try and determine if they may be useful in assessing Kaposi's sarcoma lesions using non-invasive methods. Patients can elect to not have any imaging performed without jeopardizing their participation in other protocols in the NIH Clinical Center.
Clinical trial: NCT00026793
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:  
- The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people.  
- National Cancer Institute Institutional Review Board
When we report the results of this research study, we may include photographs and images taken during the course of the study. We will not mention you by name and we will take care so that you will not be recognizable (i.e. no identifiable images of your face will be shown).
Clinical trial: NCT00026793
Section: Duration of Study Involvement
Subsections: During The Study

During your participation in this protocol, these experimental imaging techniques will be performed when you begin the study as a baseline evaluation, and then once about every 3 months while you are on the study in order to compare the results of the tests over time. Also, if your Kaposi's sarcoma should improve or worsen, or you change therapy for your KS, the imaging techniques may be repeated in an effort to correlate the findings of the imaging with the clinical changes observed in your KS. In general, we will try to schedule the examinations on this protocol to take place on the same days you are being seen in the clinic for other purposes.
Clinical trial: NCT00026793
Section: Participant's Rights
Subsections: Research Subject'S Rights What Are The Costs Of Taking Part In This Study?

If you choose to take part in the study, the following will apply, in keeping with the NIH policy:  
- You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
- There are limited funds available to cover the cost of some tests and procedures performed outside the Clinical Center, NIH. You may have to pay for these costs if they are not covered by your insurance company.  
- Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
- Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.
Participation in this protocol is voluntary you may discontinue your participation in this investigational protocol at any time. You will be given a copy of the consent for your records. There are no penalties imposed on you for withdrawing your participation in the protocol. You may ask questions of the staff, and indeed you are encouraged to do so. Any significant new findings that relate to your treatment will be discussed with you. It is important to stress that participation in this protocol does not constitute a promise of long-term medical care here at the NIH Clinical Center. If there is no research study suitable for you and your state of disease, you will be returned to the care of your private doctor.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 01-C-0158 CONTINUATION: page 5 of 8 pages
Clinical trial: NCT00026793
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect From Being In This Study?|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

The risks of participating in this study are minimal. There are no invasive procedures involved other than the drawing of a small amount of blood from your vein through a needle, which will be done by standard procedures. The imaging techniques use a variety of methods as described  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 01-C-0158 CONTINUATION: page 4 of 8 pages above to estimate the vascularity in the lesions and blood flow in the lesions. The techniques will require your time, which may be inconvenient to you. The time will vary according to how many lesions are studied by the techniques. If you find that the amount of time you have to spend having the lesions assessed is too great, we will minimize the number of lesions studies by the techniques, if possible.

There are no direct benefits to you of participation in the study. The study is an attempt to develop new methods for assessing Kaposi's sarcoma skin lesions using non-invasive methods.
Clinical trial: NCT00026793
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study?

On this protocol, you will have conventional photographs made of your lesions, and four additional experimental methods performed. The four methods are called:
1) laser Doppler imaging 2) multi-spectral imaging 3) infrared thermal imaging, and 4) optical coherence tomography.  
In addition, comparisons will be made with normal skin surrounding the lesions or on the opposite side of your body. Laser Doppler imaging takes about 3 minutes to perform on each lesion. It uses a low power laser beam that scans across the skin lesion being measured. The instrument does not touch your skin. You may be asked to have a blood pressure cuff put on your arm and have laser Doppler imaging performed before and after the cuff is inflated for a short time (generally less than thirty seconds).We do not believe that this instrument will harm your skin: in standard practice a similar machine is used to measure how deeply severe burns affect the skin. If you stare at a laser light it could harm your eyes, but precautions will be taken so that you will not stare at it. It is also used to assess allergic responses in the skin. However, its use in Kaposi's sarcoma is experimental. The purpose of this experimental use is to attempt to measure the amount of blood flow through the blood vessels in the Kaposi's sarcoma lesions. It will not have a therapeutic effect on the lesions. The multi-spectral imaging exam should take about 2 minutes to perform on each lesion. It uses principles of the way hemoglobin absorbs light. Hemoglobin is a protein in the blood that carries oxygen to your tissues. The light on the multi-spectral imaging instrument is absorbed differently depending on whether the hemoglobin has oxygen attached to it or not. This will allow an estimate to be made regarding the total blood STUDY NUMBER: 01-C-0158 CONTINUATION: page 3 of 8 pages volume, and how much of it is carrying oxygen or not. We do not believe that the instrument will harm you. The technique will not make your Kaposi's sarcoma improve. The thermal imaging takes about a minute to perform on each lesion. It uses a special camera to take digital infrared pictures of your skin. This enables us to form a picture of the temperature of your KS lesions and thus assess the blood flow in the Kaposi's sarcoma lesions. We do not believe that the camera and lights will harm you. The spectral domain optical coherence tomography (OCT) exam should take less than 2 minutes per lesion. This technique allows a three dimensional image to be made of the lesion structure. The principle of OCT is based on interference of two light beams, one illuminating and reflecting from the sample and the second one reflecting from a mirror. The light source used is of low power and non-invasive. The system will be placed approximately 4cm away from your skin, and nothing should contact your skin directly. The structural information obtained by this technique will be correlated to the vascular information obtained with the other techniques and will help to further evaluate treatment outcome. We do not believe that the instrument will harm you. We anticipate that the whole exam (involving the four tests) will generally take an hour or less to perform. You may also be asked to have a small amount of blood (less than a tablespoon) drawn from your vein for a complete blood count the days you have the lesion assessments performed. You may occasionally be asked to have two examinations performed the same day if your schedule permits. We do not expect that any of these tests will make your HIV infection or Kaposi's sarcoma improve or become more severe.
Clinical trial: NCT00026793
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

This is a research study to develop noninvasive methods of determining the density of blood vessels and the amount of blood flow in skin that is affected by Kaposi's sarcoma. The intent is to develop techniques that may in the future help us better assess the clinical state of Kaposi's sarcoma lesions. Why are you being asked to take part in this study? You are being asked to take part in this study because you have Kaposi's Sarcoma.  
STUDY NUMBER: 01-C-0158 CONTINUATION: page 2 of 8 pages
Clinical trial: NCT00026793
Section: Voluntary Participation
Subsections: Optional Studies|Yes No Initials_________

We would like to keep some of the imaging studies and data that are collected for future research. These imaging studies and data will be identified by a number and not your name. The use of your imaging studies and data will be for research purposes only and will not benefit you. It is also possible that the stored imaging studies and data may never be used. Results of research done on your imaging studies and data will not be available to you or your doctor. It might help people who have cancer and other diseases in the future. If you decide now that your imaging studies and data can be kept for research, you can change your mind at any time. Just contact us and let us know that you do not want us to use your specimens and/or data. Then any specimens that remain will be destroyed and your data will not be used for future research. Please read each sentence below and think about your choice. After reading each sentence, circle and initial the answer that is right for you. No matter what you decide to do, it will not affect your care.  
1. My imaging studies and data may be kept for use in research to learn about, prevent, or treat cancer. Yes No Initials_________
2. My imaging studies and data may be kept for use in research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease).

3. Someone may contact me in the future to ask permission to use my imaging studies and/or data in new research not included in this consent. Yes No Initials_________  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 01-C-0158 CONTINUATION: page 7 of 8 pages
Clinical trial: NCT00026793
Section: Withdrawal from Study
Subsections: Stopping Participation

Your doctor may decide to stop your participation in this study  
- if he/she believes that it is in your best interest
- if you do not follow the study requirements
In this case, you will be informed of the reason that your participation is being stopped. You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines, information collected on you up to that point may still be used by the researchers. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot be recalled and destroyed.  
Any decisions regarding therapy of your Kaposi's sarcoma will be made by your treating physician using regular clinical information (including counts and measurements of lesions). The results of the non-invasive imaging will not be used to alter your clinical care, as at present these are research tools only. If you are enrolled on a research treatment study for Kaposi's sarcoma, the decisions about your treatment will be made by your treating physician in accordance with the requirements of that study.