Clinical trial · Interventional
Imaging Study for FdCyd and THU Cancer Treatment
Phase 0 Trial of [F-18]-5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow, insufficient accrual.
Summary
Brief summary (as posted)
Background: \- The drugs FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how FdCyd works in the body. Researchers want to look at a modified form of FdCyd using imaging studies to see how the drug reacts with the cancer. This study is not a treatment study. It is open only to people who are already on the FdCyd and THU cancer treatment study. Objectives: \- To study how FdCyd affects advanced cancer cells. Eligibility: \- Participants in National Cancer Institute study 09-C-0214. Design: * Participants will have two imaging studies, one before starting FdCyd and THU treatment and one after starting treatment. * Participants will have the modified FdCyd, known as F-18 FdCyd, with a dose of THU. The doses will be followed by two imaging study scans and frequent blood samples. * This procedure will be repeated at a later date, during the FdCyd and THU treatment period. * Treatment will not be provided as part of this study. This is an imaging study protocol only....
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [F-18]-5-FLUORO-2'-DEOXYCYTIDINE | Drug | 5-Fluoro-2-Deoxycytidine | ALIAS |
| Positron emission tomography (PET)/Computed tomography (CT) | Diagnostic Test | — | UNRESOLVED |
| Tetrahydrouridine intravenous (IV) | Drug | — | UNRESOLVED |
| Tetrahydrouridine (oral) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1/Intravenous (IV) Tetrahydrouridine (THU)
- description
- \[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
- interventionNames
- Drug: [F-18]-5-FLUORO-2'-DEOXYCYTIDINE
- Drug: Tetrahydrouridine intravenous (IV)
- Drug: Tetrahydrouridine (oral)
- Diagnostic Test: Positron emission tomography (PET)/Computed tomography (CT)
- type
- EXPERIMENTAL
- label
- 2/Oral Tetrahydrouridine (THU)
- description
- \[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
- interventionNames
- Drug: [F-18]-5-FLUORO-2'-DEOXYCYTIDINE
- Drug: Tetrahydrouridine intravenous (IV)
- Drug: Tetrahydrouridine (oral)
- Diagnostic Test: Positron emission tomography (PET)/Computed tomography (CT)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * Enrolled in the National Institutes of Health (NIH) Phase II Clinical protocol evaluating 5-fluro-2'-deoxycytidine (FdCyd) with Tetrahydrouridine (THU) (09-C-0214) with target lesion measured as greater than or equal to 10mm with spiral computed tomography (CT) scan. * Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines * For females: Negative serum pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy EXCLUSION CRITERIA: * Participants with severe claustrophobia unresponsive to oral anxiolytics * Subjects weighing \> 400 lbs (weight limit for scanner table), or unable to fit within the imaging gantry * Known allergy to FdCyd * The subject is unable to lie still for 75 minutes * 5 Pregnant or lactating women. Pregnant women are excluded from this study because the effects of 18F-FdCyd in pregnancy are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 18F-FdCyd in the mother, breastfeeding should be discontinued if the mother receives 18F-FdCyd * Participants with any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results
References
Publications (3)
- BACKGROUNDCarter SK. Editorial: Large-bowel cancer-The current status of treatment. J Natl Cancer Inst. 1976 Jan;56(1):3-10. doi: 10.1093/jnci/56.1.3. No abstract available. PMID 1255749
- BACKGROUNDDoroshow JH, Multhauf P, Leong L, Margolin K, Litchfield T, Akman S, Carr B, Bertrand M, Goldberg D, Blayney D, et al. Prospective randomized comparison of fluorouracil versus fluorouracil and high-dose continuous infusion leucovorin calcium for the treatment of advanced measurable colorectal cancer in patients previously unexposed to chemotherapy. J Clin Oncol. 1990 Mar;8(3):491-501. doi: 10.1200/JCO.1990.8.3.491. PMID 2407810
- BACKGROUNDHARTMANN JR, ORIGENES ML Jr, MURPHY ML, SITARZ A, ERLANDSON M. EFFECTS OF 2'-DEOXY-5-FLUOROURIDINE (NSC-27640) AND 5-FLUOROURACIL (NSC-19893) ON CHILDHOOD LEUKEMIA. Cancer Chemother Rep. 1964 Jan;34:51-4. No abstract available. PMID 14116219