Clinical trial: NCT00775268
Section: Participant's Rights
Subsections: Research Subject'S Rights

Participation in this research study is voluntary and you can withdraw at any time. We encourage you to ask questions so you can make the most informed decisions during your participation in this study. Refusal to participate will not result in penalty or less benefits to which you are otherwise entitled. It is important to stress that being in this protocol does not promise long-term medical care at the NIH Clinical Center. If there is no further research study that is suitable for you and your state of disease, or if you are not currently on another research study, you will be returned to the care of your referring doctor or institution, or alternative sources of care closer to your home. If you have any questions about your treatment at NIH, you can contact the Principal Investigator, Dr. Karen A. Kurdziel (301-443-0622) or the patient care representative (301-496-2626). A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Clinical trial: NCT00775268
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation|Possible Risks From Having An Intravenous (Iv) Injection:|Possible Risks From Radiation Exposure:

There are a few possible risks of [F-18]FLT PET and PET/CT scans. The most common ones are not considered serious. Any serious risks of [F-18]FLT PET or PET/CT scans are considered very unlikely. All of the known risks are described below.

- Bruising, pain, or infection at the injection site - Leaking of IV fluid into tissues near the injection
- Inflammation of the vein at the injection site
- Allergic reaction, which could be serious or life threatening
- Dizziness if you stand up quickly

- Each dose of [F-18]FLT will expose you to about [e.g. one-half to three –quarters] of the amount of radiation in a routine CT scan of a large body area such as your  
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: 08-C-0200 CONTINUATION: page 4 of 7 pages abdomen. Because we also need to do a CT, along with the [F-18]FLT PET, you could get up to another full CT dose of radiation at each scan depending on the scanner used.  
A total of 3 FLT PET/CT scans will be performed. Using the standard way of describing radiation dose, from participating in this study and undergoing all 3 FLT PET/CT scans, you will receive approximately 9.7 rem to your liver, 8.2 rem to your stomach, and your adrenals, 8.1 rem to your pancreas, and 7.9 rem to your small intestines. All other organs will receive smaller amounts of radiation. Although each organ will receive a different dose, the amount of radiation exposure you will receive from these procedures is equal to a uniform whole-body exposure of 4.2 rem. This calculated value is known as the "effective dose" and is used to relate the dose received by each organ to a single value. The amount of radiation received in this study is within the dose guidelines established by the NIH Radiation Safety Committee for research subjects. The guidelines is an effective dose of 5 rem (or 5,000 mrem) received per year. For comparison, the average person in the United States receives a radiation exposure of 0.3 rem per year from natural background sources, such as from the sun, outer space, and from radioactive materials that are found naturally in the earth's air and soil. The dose that you will receive from this research study is about the same amount you would normally receive in 13.7 years from these natural sources. The effects of radiation exposure on humans have been studied for over 60 years. In fact, these studies are the most extensive ever done of any potentially harmful agent that could affect humans. In all these studies, no harmful effects were ever observed from the levels of radiation you will receive by taking part in this research study. However, scientists disagree on whether radiation doses at these levels are harmful. Even though no effects have been observed, some scientists believe that radiation can be harmful at any dose - even low doses such as those received during this research. If you would like more information about radiation and examples of exposure levels from other sources, please ask the investigator for a copy of the pamphlet called, An Introduction to Radiation for NIH Research Subjects. Please tell your doctor if you have taken part in other research studies or received any medical care at the NIH or other places/hospitals that used radiation. This way we can make sure that you will not receive too much radiation. Consider xrays taken in radiology departments, cardiac catheterization, and fluoroscopy as well as nuclear medicine scans in which radioactive materials were injected into your body. Experimental FLT PET imaging may reveal new information that would result in further studies (e.g., biopsies) and interventions that might not be necessary. The decision to act on findings on the experimental FLT PET study will be made by you and your referring physician.  
STUDY NUMBER: 08-C-0200 CONTINUATION: page 5 of 7 pages It is possible that you may experience some side effects that we cannot anticipate. For that reason, you will be watched closely so that we can treat any side effects early.
Clinical trial: NCT00775268
Section: Purpose of Research
Subsections: Description Of Research Study

You have been invited to participate in this study because you have lymphoma. As standard of care, your doctor will obtain conventional PET/CT scans to evaluate your response to chemotherapy. Conventional PET/CT scans are typically done using a sugar-like radioactive tracer called FDG and low dose x-rays. They are usually performed before treatment and after the completion chemotherapy. Even though, FDG PET/CT is valuable in monitoring treatment response, we hope that a new PET radioactive tracer called 18F- fluorothymidine (FLT) PET/CT
will be better able predict final response to treatment. We will work with your clinical provider to see if this early imaging helped predict your response to therapy.  
PATIENT IDENTIFICATION CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH **STUDY**  
- Adult Patient or - Parent, for Minor Patient  
NIH-2514-1 (07-09) P.A.: 09-25-0099  
File in Section 4: Protocol Consent (2)  
STUDY NUMBER: 08-C-0200 CONTINUATION: page 2 of 7 pages Positron emission tomography/computed tomography (PET/CT) is a type of scan that uses a large donut shaped detection device. The scanner contains crystals that pick up tiny radiation signals given off by radioactive substances (tracers) that have been injected into the vein. The images generated by the scanner show where the radioactive tracer is in the body. The CT portion of the PET/CT is performed with low dose x-rays that go through your body and help us to better localize where the radioactive tracer is concentrating. FLT is an experimental tracer which has high uptake in tissues involved in cellular division such as tumors. By injecting a small amount intravenously, we can image where FLT accumulates in the body. Numerous small PET studies using FLT have been performed with no adverse effects ever reported. By enrolling is this study, you will be asked to undergo an FLT PET/CT scan: before beginning therapy, after 2 cycles of therapy and following completion of your chemotherapy. It is generally standard of care to undergo FDG PET/CT imaging prior to beginning treatment and at the completion of therapy. Some small studies have suggested that FDG PET/CT performed during therapy may be predictive of outcome. For this study, we are asking you to undergo an additional mid-therapy FDG PET/CT study, which will be compared with the mid treatment FLT PET/CT. You will also be giving us permission to collect follow-up information regarding your progress for up to three years after treatment. There may be additional blood tests performed before the FLT PET scan can be scheduled. These are to be as certain as we can that the injection of FLT will not cause side effects. These tests will be performed to assess your liver function and will require about two teaspoonfuls of blood. Women able to have children will have an additional teaspoonful of blood collected in order to test for pregnancy. Pregnant women cannot participate in this study due to potential negative health effects to the unborn baby. On each day of your FLT PET/CT studies, you will come to the Nuclear Medicine Department at NIH and an intravenous line will be placed in your arm. You will be asked to lie on your back at the PET/CT scanner table. The table will then be advanced into the scanner. FLT will be injected in the vein over a 10-15 second period. Subsequently, PET/CT imaging over the tumor will be performed for 60 minutes, and immediately afterwards, a whole body scan will be performed (an additional 25-35 minutes). It is important that you remain still during these scans. 120 minutes after the injection, another regional (with your target tumor in the field of view) PET/CT images will be performed in a similar fashion for 10 minutes. Please note that for the additional sets of images re-injection of tracer is not necessary. Doctors and nurses will be supervising the whole procedure and you should ask them any questions you have concerning this study. Additional  
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: 08-C-0200 CONTINUATION: page 3 of 7 pages blood samples (two teaspoons) will be collected from your vein at 60 and 120 minutes after the FLT injection to determine the amount of FLT that remains in your blood. For the mid-therapy FDG study, you will also come to the Nuclear Medicine Department at NIH and an intravenous line will be placed in your arm. You will be asked to lie on your back at the PET/CT scanner table. The table will then be advanced into the scanner. FDG will be injected in the vein over a 10-15 second period. One hour after injection a whole body PET/CT will be performed (lasting ~25-35 minutes). Up to 40 subjects will be enrolled in this arm of the trial. Patients will be enrolled at either the NIH Clinical Center or the Walter Reed National Military Medical Center.