Clinical trial · Interventional
Pilot Imaging Study of Leukemia
Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging
NCT03633955CI-TRIAL-00109232REALIZErecruitingPhase 1ClinicalTrials.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 is a prospective pilot study, the primary aim of which is to determine whether the presence of 18F FLT imaging signal uptake abnormalities correlate with clinically validated evidence of hematopoietic malignant disease (e.g. MRD, molecular, flow or histology) after immunotherapy and other treatments.
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 |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Ambiguous Lineage Leukemia or Lymphoma | — | UNRESOLVED | — |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Standard therapy - Acute leukemia cohort
- description
- The Arm will accrue patients receiving standard therapy from the high-risk acute leukemia cohort (18 patients).
- interventionNames
- Drug: FLT
- type
- EXPERIMENTAL
- label
- Immunotherapy - Acute leukemia cohort
- description
- The Arm will accrue patients receiving immunotherapy from the high-risk acute leukemia cohort (18 patients).
- interventionNames
- Drug: FLT
- type
- ACTIVE_COMPARATOR
- label
- Standard therapy - Myeloma cohort
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 4 to 80 years 2. Evidence of high-risk hematopoietic malignancy with relapsed/refractory disease: acute lymphocytic leukemia, Acute myeloid leukemia, Ambiguous lineage leukemia, myeloma 3. Karnofsky/Lansky score of ≥ 50 4. Agree to use contraceptive measures during study protocol participation (when age appropriate) 5. Patient or parent/guardian capable of providing informed consent. 6. Ability to undergo 18F FLT imaging without sedation 7. Bilirubin \< 2.5 mg/dL, AST/ALT \<5x upper limit of normal, Serum creatinine \< 1.0 or 2x the upper limit of normal (whichever is higher) 8. Pulse oximetry of \> 90% on room air 9. Ability to undergo 18F FLT imaging without sedation 10. Anticipated immunotherapy (Arm A to include patients who received immune therapy with co-enrollment on a separate protocol or other immunotherapy) and Arm B, those who received other non-immune therapies to treat their cancers (excludes HSCT but includes chemotherapy or non-HSCT radiotherapy). Exclusion Criteria: 1. Patients with uncontrolled infections 2. Pregnancy or lactating 3. History of prior fluorothymidine allergy or intolerance.
References
Publications (0)
Data not yet available
No reference posted for this study.