124I-FIAU Imaging in EBV and KSHV Associated Cancers (NCT00982449) | Clinical Trial Compass
CompletedNot Applicable
124I-FIAU Imaging in EBV and KSHV Associated Cancers
United States12 participantsStarted 2010-12
Plain-language summary
This research is being done to determine whether viral thymidine kinase (TK) expression in Epstein-Barr virus (EBV) and Kaposi's sarcoma herpesvirus (KSHV) virus-associated tumors is sufficient to image.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 years or older.
. EBV-positive or KSHV-associated malignancy, including but not limited to:
. Measurable disease (at least one lesion measuring \> 2 cm in longest axis).
. ECOG performance status of 0, 1, or 2.
. Patients must be able to lie flat for at least 60 minutes and fit on PET-CT scanner.
. For post-therapy imaging with FIAU-PET, treatment with standard or investigational agents that can potentially activate herpesvirus TK, including but not limited to the following. Concurrent radiation therapy is permissible:
. AST and ALT \< 3 X upper limit of normal, unless attributed to tumor, obtained within 2 weeks prior to registration.
. Serum creatinine \< 2.0 mg/dL, within 2 weeks prior to registration.
Exclusion criteria
. End-stage liver disease unrelated to tumor.
. Known active or chronic hepatitis B or hepatitis C infection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the potential for enzymatic targeting as evidenced by the ability to image 124I-FIAU tracer uptake in tumor at baseline and following chemotherapy or biologic therapy with agents that may induce viral TK activation.
Timeframe: Baseline, Days 1-3 post chemo
Trial details
NCT IDNCT00982449
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins