Clinical trial · Interventional
Study of [F 18]HX4 Positron Emission Tomography (PET) as a Tool to Detect Hypoxia in Tumors
A Pilot, Phase II , Open Label, Nonrandomized, Multi- Center Study of [F 18]HX4 Positron Emission Tomography (PET) to Detect Hypoxia in Tumors
NCT01075399CI-TRIAL-00011965HX4-200completedPhase 2Results 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)
This pilot phase II study is designed as a test and retest study to investigate \[F 18\]HX4 as a reliable non-invasive PET imaging marker for detection of tumor hypoxia regions and to establish a threshold for \[F 18\]HX4 uptake in the tumor. The study will evaluate the relationship between hypoxia biomarkers (HIF1α and CA-IX) by immunohistochemistry (IHC) and tumor uptake of \[F 18\]HX4 by PET imaging.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [F 18]HX4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [F 18]HX4
- description
- \[F18\]HX4, 10 mCi, is administered in a single intravenous bolus injection, followed by a saline flush.
- interventionNames
- Drug: [F 18]HX4
Primary outcomes (1)
- measure
- Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors
- timeFrame
- Time between 1st and 2nd scan was 1 to 6 days
- description
- Primary tumor uptake of \[F 18\]HX4 was measured on PET images by onsite radiologist or nuclear medicine physician for 1st and 2nd PET scans. Values measured were: SUV (Standard Uptake Value), SUV Max (Maximum standard uptake value), SUV Mean (Mean standard uptake value), and T/B ratio (Tumor to background ratio). Pearson's correlation coefficient was calculated for each of the parameter.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is \>18 years and male or female of any race / ethnicity * Patient or patient's legally acceptable representative provides written informed consent and is willing to comply with protocol procedures * Patient must have histopathologically confirmed head/neck, lung, liver, rectal or cervical cancer with tumor size ≥ 3cm * Patient has tumor tissue samples available before treatment for future immunohistochemistry biomarker tests (HIF1alpha and CA-IX) * Patient is scheduled to have or already had a clinical \[F 18\]FDG PET/CT scan recommended to be within 14 days of the first pre-treatment \[F 18\]HX4 PET/CT scan and have no treatment intervention in between these two scans * Patient is scheduled or is intended to be scheduled to receive chemotherapy, radiation or chemoradiotherapy treatment(s) after the pre-treatment \[F 18\]HX4 PET/CT and \[F 18\]FDG PET/CT scans for his/her cancer care * Patient must have hepatic and renal functions as defined by laboratory results within the following ranges: * Total bilirubin within 2 times institutional upper limit of normal * AST (SGOT) and ALT (SGPT) ≤ 2.5 times institutional upper limits of normal * Serum creatinine ≤ 2.5 times institutional limit of normal * BUN within 2 times institutional upper limit of normal Exclusion Criteria: * Patient is not capable of complying with study procedures * Female patient is pregnant or nursing o Exclude the possibility of pregnancy by one of the following: * Confirming in medical history that the patient is post-menopausal for a minimum of one year, or surgically sterile * Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera, or Norplant * Confirming a negative urine dipstick test taken the morning of but before receiving \[F 18\]HX4 * Patient has been involved in an investigative, radioactive research procedure within 7 days and during the study participation period * Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data
References
Publications (0)
Data not yet available
No reference posted for this study.