Clinical trial · Interventional
Oxygen Measurements in Subcutaneous Tumors by EPR Oximetry Using OxyChip
A Single-Institutional, Phase 1 Trial of Repeated Oxygen Measurements in Subcutaneous Tumors by Electron Paramagnetic Resonance (EPR) Oximetry Using an Implantable Oxygen Sensor (OxyChip)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study halted prematurely but potentially will resume
Summary
Brief summary (as posted)
Tumors with low oxygen levels are associated with poor prognosis and resistance to standard radiotherapy or systemic therapies. The ability to make repeated oxygen measurements in tumors could be used to help select the most effective treatment or the best timing to start therapies. The purpose of this study is to ascertain the safety and feasibility of using an implantable oxygen sensor, known as the OxyChip, to make oxygen measurements in tumors using EPR oximetry, a technique related to magnetic resonance imaging (MRI).
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 |
|---|---|---|---|
| Neoplasms, Benign | Benign Neoplasm | ALIAS | 0.90 |
| Neoplasms, Malignant | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OxyChip | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IA No treatment except standard-of-care (SOC) surgery
- description
- Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IA, patients will not have any cancer therapy prior to removal of the OxyChip and duration of implantation is typically less than 4 weeks but may be up to 52 weeks.
- interventionNames
- Device: OxyChip
- type
- EXPERIMENTAL
- label
- IB SOC adjuvant therapy and SOC surgery
- description
- Placement of OxyChip will be through a minimally invasive procedure (needle injection) and removal will be at the time of surgical resection. In Phase IB, patients will have standard of care neoadjuvant chemotherapy or pre-operative radiation therapy during the time that the OxyChip is within the tumor, which is typically 6 weeks but may be up to 52 weeks.
- interventionNames
- Device: OxyChip
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Phase IA: Any tumor identified by imaging or physical exam to be accessable to OxyChip implantation and measurements and that is going to receive surgical resection with intent to remove the entire tumor. The tumor must be sufficiently large to accommodate the OxyChip. 2. Phase IB: Any biopsy-proven malignancy expected to undergo neoadjuvant chemotherapy or radiotherapy prior to resection. The tumor must be sufficiently large to accommodate the OxyChip. 3. The tumor must be within 3 cm of the surface of the skin or mucosa. 4. Age ≥18 years old. 5. Subject must be capable of giving informed consent. 6. Anticipated time between implantation and planned surgical excision of at least three days. 7. Tumors must be \> 2.5 cm in minimum diameter to be eligible. Exclusion Criteria: 1. Pregnant women or women of childbearing potential without adequate contraception. Contraception, which can include abstinence, is required from the first day of the last menstrual period until the removal of the OxyChip. 2. Receipt of concurrent chemotherapy and radiotherapy, or planned sequential chemotherapy and radiotherapy, prior to resection (Phase IB), 3. Receipt of Avastin, or other angiogenesis inhibitors, during the study. 4. Prior radiotherapy to the site of implantation. 5. Having other implanted (not removable) devices that generate electrical artifacts or that could be altered by the EPR magnetic field, such as cardiac pacemakers or defibrillators. 6. Concurrent enrollment in any clinical research study, in the absence of cancer recurrence, in which the other study can reasonably be anticipated to have the potential for causing adverse events that would affect our primary endpoint of assessing the safety of the OxyChip device. If a study is not felt to impact the evaluation of adverse events in this trial then the patient will be eligible for concurrent enrollment. In the presence of confirmed clinical recurrence after initial cancer therapy (and after removal of OxyChip) during the year-long follow up stipulated in the protocol, patients will be eligible for all clinical trials as deemed appropriate by the treating oncologist. 7. Patient platelet blood count \< 50,000/l of blood, and absolute neutrophil count \< 1,000/l of blood. Laboratory values must be obtained at least 3 months prior to implantation of the OxyChip.
References
Publications (19)
- BACKGROUNDBrizel DM, Dodge RK, Clough RW, Dewhirst MW. Oxygenation of head and neck cancer: changes during radiotherapy and impact on treatment outcome. Radiother Oncol. 1999 Nov;53(2):113-7. doi: 10.1016/s0167-8140(99)00102-4. PMID 10665787
- BACKGROUNDVaupel P, Thews O, Hoeckel M. Treatment resistance of solid tumors: role of hypoxia and anemia. Med Oncol. 2001;18(4):243-59. doi: 10.1385/MO:18:4:243. PMID 11918451
- BACKGROUNDSwartz HM, Walczak T. Developing in vivo EPR oximetry for clinical use. Adv Exp Med Biol. 1998;454:243-52. doi: 10.1007/978-1-4615-4863-8_29. PMID 9889898
- BACKGROUNDDoll CM, Milosevic M, Pintilie M, Hill RP, Fyles AW. Estimating hypoxic status in human tumors: a simulation using Eppendorf oxygen probe data in cervical cancer patients. Int J Radiat Oncol Biol Phys. 2003 Apr 1;55(5):1239-46. doi: 10.1016/s0360-3016(02)04474-7. PMID 12654433
- BACKGROUNDGagel B, Piroth M, Pinkawa M, Reinartz P, Zimny M, Kaiser HJ, Stanzel S, Asadpour B, Demirel C, Hamacher K, Coenen HH, Scholbach T, Maneschi P, DiMartino E, Eble MJ. pO polarography, contrast enhanced color duplex sonography (CDS), [18F] fluoromisonidazole and [18F] fluorodeoxyglucose positron emission tomography: validated methods for the evaluation of therapy-relevant tumor oxygenation or only bricks in the puzzle of tumor hypoxia? BMC Cancer. 2007 Jun 28;7:113. doi: 10.1186/1471-2407-7-113. PMID 17598907
- BACKGROUNDVaupel P, Mayer A. Hypoxia in cancer: significance and impact on clinical outcome. Cancer Metastasis Rev. 2007 Jun;26(2):225-39. doi: 10.1007/s10555-007-9055-1. PMID 17440684
- BACKGROUNDCosse JP, Michiels C. Tumour hypoxia affects the responsiveness of cancer cells to chemotherapy and promotes cancer progression. Anticancer Agents Med Chem. 2008 Oct;8(7):790-7. doi: 10.2174/187152008785914798.