Clinical trial · Interventional
124I-FIAU Imaging in EBV and KSHV Associated Cancers
Study of Imaging of Viral Thymidine Kinase Activity in EBV-Associated and KSHV-Associated Malignancies
NCT00982449CI-TRIAL-00034903completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Kaposi's Sarcoma | Kaposi Sarcoma | ALIAS | 0.90 |
| Nasopharyngeal Cancer | Malignant Nasopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FIAU-PET-CT-2 | Other | — | UNRESOLVED |
| FIAU-PET-CT-4 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 4 mCi of I-FIAU
- description
- GROUP B 1-3 days after any chemotherapy that may activate viral TK, 4 mCi of I-FIAU are administered, followed 2 - 4 hours later by FIAU-PET-CT-4.
- interventionNames
- Other: FIAU-PET-CT-4
- type
- ACTIVE_COMPARATOR
- label
- 2 mCi of I-FIAU
- description
- GROUP A 1-3 days after any chemotherapy that may activate viral TK, 2 mCi of I-FIAU are administered, followed 2 - 4 hours later by FIAU-PET-CT-2.
- interventionNames
- Other: FIAU-PET-CT-2
Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older. 2. EBV-positive or KSHV-associated malignancy, including but not limited to: * EBV+ Hodgkin lymphoma * EBV+ non-Hodgkin lymphoma or lymphoproliferative disease * Primary effusion lymphoma * Kaposi's sarcoma * EBV+ gastric cancer * EBV+ nasopharyngeal cancer 3. Measurable disease (at least one lesion measuring \> 2 cm in longest axis). 4. ECOG performance status of 0, 1, or 2. 5. Patients must be able to lie flat for at least 60 minutes and fit on PET-CT scanner. 6. 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: * Platinum compounds (for example, cisplatin, carboplatin) * Anthracyclines (for example, doxorubicin or pegylated doxorubicin) * Tubulin disrupting agents (for example, vincristine, vinblastine) * Rituximab * Gemcitabine * Cytarabine * Histone deacetylase inhibitors * Bortezomib NOTE: Patients who would not receive bortezomib as part of their usual care may receive a one-time dose of bortezomib for the purpose of imaging with 124I-FIAU and FIAU-PET-CT. 7. AST and ALT \< 3 X upper limit of normal, unless attributed to tumor, obtained within 2 weeks prior to registration. 8. Serum creatinine \< 2.0 mg/dL, within 2 weeks prior to registration. 9. In patients who will receive bortezomib for imaging purposes only: * Total bilirubin \< 1.5 X upper limit of normal, obtained within 2 weeks prior to registration. * Platelet count \> 70,000 / mm3 obtained within 2 weeks prior to registration. * No pre-existing peripheral neuropathy greater than grade 1. Exclusion Criteria: 1. End-stage liver disease unrelated to tumor. 2. Known active or chronic hepatitis B or hepatitis C infection. 3. History of iodine hypersensitivity. 4. Chronic renal insufficiency requiring dialysis. 5. Women who are pregnant or breast feeding. 6. Foreseen inability to comply with study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.