Clinical trial · Interventional
A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma
A Contiguous, Sequential Phase I/II Imaging Study of 18F-fluoro-3'-L-fluorothymidine (18F-FLT) in Patients With Known or Suspected Carcinoma of the Lung, Breast, Renal Cell, Pancreas, or Brain, and With Gastrointestinal Malignancies, Neuroendocrine Tumours or Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Retirement of former Qualified Investigator and lack of resources to complete study
Summary
Brief summary (as posted)
The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images. Tumour growth rate is a useful indicator of tumour aggression and response to treatment. Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to anticancer treatment.
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 |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FLT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 18F-FLT PET
- interventionNames
- Biological: 18F-FLT
Primary outcomes (2)
- measure
- Phase I: to determine the safety of 18 F-FLT.
- timeFrame
- 3 years
- measure
- Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores.
- timeFrame
- 3 years
Secondary outcomes (3)
- measure
- Phase I: To determine general biodistribution of 19F-FLT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required. * Patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including GGM, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion \>1 cm in diameter. * Biochemical parameters as measured are required to be within 5 times the normal limits for age. * Able and willing to follow instruction and comply with the protocol * Provide written informed consent prior to participation in the study * Karnofsky Performance Scale Score 50-100 Exclusion Criteria: * Previous removal of entire tumour * Biochemical parameters as measured outside 5 times the normal limits for age * Unable or unwilling to follow instructions and comply with the protocol * Unable or unwilling to provide written informed consent prior to participation in the study * Karnofsky Performance Scale Score \< 50 * Nursing or pregnant females * Age less than 16 years
References
Publications (0)
Data not yet available