Clinical trial · Interventional
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
This clinical trial is studying the amount of EF5 and motexafin lutetium present in tumor cells and/or normal tissues of patients with abdominal (such as ovarian, colon, or stomach cancer) or non-small cell lung cancer. EF5 may be effective in measuring oxygen in tumor tissue. Photosensitizing drugs such as motexafin lutetium are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. Knowing the level of oxygen in tumor tissue and the level of motexafin lutetium absorbed by tumors and normal tissue may help predict the effectiveness of anticancer therapy
Conditions
Conditions (71)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Carcinoma of the Appendix | Appendix Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Localized Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | CURATED_BROADER | 0.78 |
| Localized Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
| Localized Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | CURATED_BROADER |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EF5 | Drug | — | UNRESOLVED |
| motexafin lutetium | Drug | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (EF5, motexafin lutetium)
- description
- Patients receive EF5 IV over 1-2.5 hours on day 1 and motexafin lutetium IV over 10-15 minutes on day 2. Patients undergo definitive surgical resection approximately 3 hours after motexafin lutetium administration. Hypoxia and motexafin lutetium levels in the resected tumors are evaluated. Tumor to normal tissue ratios are also determined.
- interventionNames
- Drug: EF5
- Drug: motexafin lutetium
- Other: pharmacological study
Primary outcomes (4)
- measure
- Motexafin lutetium uptake in tumors and normal tissues
- timeFrame
- At the time of surgery
- description
- Data will be described using graphical techniques (e.g., box plots) and summary statistics (e.g., means, medians, standard deviations, and interquartile ranges). For each patient, the mean concentration of motexafin lutetium across tumor and normal samples will be summarized.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed or suspected diagnosis of 1 of the following:
* Intra-abdominal malignancy of 1 of the following types:
* Sarcoma
* Ovarian cancer
* Gastrointestinal malignancies, including, but not limited to, appendiceal cancer, colon cancer, or gastric cancer
* Non-small cell lung cancer
* Planning to undergo surgical resection of disease
* Disease has the propensity to spread to the peritoneal cavity (intra-abdominal malignancy patients)
* Performance status - ECOG 0-2
* WBC ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin \< 1.5 mg/dL
* Creatinine normal
* Creatinine clearance ≥ 60 mL/min
* Body weight ≤ 130 kg
* No G6PD deficiency
* No porphyria
* No history of peripheral neuropathy ≥ grade 3
* Able to tolerate anesthesia and major surgery
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 month after study participationReferences
Publications (0)
Data not yet available