Clinical trial · Interventional
A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation
A Phase II/III, Open Label, Non-Randomized, Multi - Center Study Of Positron Emission Tomography (PET) Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
NCT00847509CI-TRIAL-00012288FLT101completedN/AResults postedClinicalTrials.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)
Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre therapy PET/CT imaging visit, and one (3-5 weeks after the start of therapy) post PET/CT imaging visit. This study will evaluate the FLT and FDG images for tumor proliferation rates for early assessment of tumor response to radiation or chemo-radiation combo.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [F-18]FLT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FLT PET scan
- description
- Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate \[F-18\] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard \[F-18\] FDG PET will be the active comparator.
- interventionNames
- Drug: [F-18]FLT
Primary outcomes (1)
- measure
- [F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan
- timeFrame
- 3-5 weeks after the start of radiation or chemo radio therapy
- description
- The sponsor decided not to further develop \[F-18\]FLT. Therefore, no further analysis was performed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient provides written Informed Consent and is willing to comply with protocol requirements * Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity) * Patient is capable of lying still in the PET scanner for the protocol required time frame(s) * Patient has a diagnosis of one of the following malignancies using the TNM Staging System: * Lung cancer (T3 grade up, node positive, but no metastatic disease) * Head and neck cancer (T3 grade up, node positive, but no metastatic disease) * Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas * Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent * As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical \[F-18\]FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy) * Patient is scheduled to have the investigational, pre treatment \[F-18\] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment \[F-18\] FDG PET scan * Patient has not received or intends to receive 5-fluorouracil (chemotherapeutic agent) * Patient has a score of greater than or equal to (\>/=) 60% on the Karnofsky Performance Status Scale Exclusion Criteria: * Patient is a pregnant or lactating female. Exclude the possibility of pregnancy: * by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration * by surgical history (eg, tubal ligation or hysterectomy) * by patient's history of being post menopausal with a minimum 1 year without menses * Patient is undergoing treatment with palliative intent * Patient has received an investigational compound and/or medical device within 14 days before admission into this study * Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations * Patient is determined by the Investigator that he/she is clinically unsuitable for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.