Neoplasms, Malignant Clinical Trial
Official title:
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)
Verified date | September 2023 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 25 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Periannan Kuppusamy | National Cancer Institute (NCI) |
United States,
Brizel 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. — View Citation
Cardenas-Navia LI, Mace D, Richardson RA, Wilson DF, Shan S, Dewhirst MW. The pervasive presence of fluctuating oxygenation in tumors. Cancer Res. 2008 Jul 15;68(14):5812-9. doi: 10.1158/0008-5472.CAN-07-6387. — View Citation
Cardenas-Navia LI, Yu D, Braun RD, Brizel DM, Secomb TW, Dewhirst MW. Tumor-dependent kinetics of partial pressure of oxygen fluctuations during air and oxygen breathing. Cancer Res. 2004 Sep 1;64(17):6010-7. doi: 10.1158/0008-5472.CAN-03-0947. — View Citation
Cosse 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. — View Citation
Doll 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. — View Citation
Gagel 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. — View Citation
Meenakshisundaram G, Eteshola E, Pandian RP, Bratasz A, Selvendiran K, Lee SC, Krishna MC, Swartz HM, Kuppusamy P. Oxygen sensitivity and biocompatibility of an implantable paramagnetic probe for repeated measurements of tissue oxygenation. Biomed Microdevices. 2009 Aug;11(4):817-26. doi: 10.1007/s10544-009-9298-4. — View Citation
Meenakshisundaram G, Pandian RP, Eteshola E, Lee SC, Kuppusamy P. A paramagnetic implant containing lithium naphthalocyanine microcrystals for high-resolution biological oximetry. J Magn Reson. 2010 Mar;203(1):185-9. doi: 10.1016/j.jmr.2009.11.016. Epub 2009 Nov 26. — View Citation
O'Hara JA, Blumenthal RD, Grinberg OY, Demidenko E, Grinberg S, Wilmot CM, Taylor AM, Goldenberg DM, Swartz HM. Response to radioimmunotherapy correlates with tumor pO2 measured by EPR oximetry in human tumor xenografts. Radiat Res. 2001 Mar;155(3):466-73. doi: 10.1667/0033-7587(2001)155[0466:rtrcwt]2.0.co;2. — View Citation
O'Hara JA, Goda F, Dunn JF, Swartz HM. Potential for EPR oximetry to guide treatment planning for tumors. Adv Exp Med Biol. 1997;411:233-42. doi: 10.1007/978-1-4615-5865-1_28. No abstract available. — View Citation
Pandian RP, Dolgos M, Marginean C, Woodward PM, Hammel PC, Manoharan PT, Kuppusamy P. Molecular packing and magnetic properties of lithium naphthalocyanine crystals: hollow channels enabling permeability and paramagnetic sensitivity to molecular oxygen. J Mater Chem. 2009;19(24):4138-4147. doi: 10.1039/b901886g. — View Citation
Pandian RP, Parinandi NL, Ilangovan G, Zweier JL, Kuppusamy P. Novel particulate spin probe for targeted determination of oxygen in cells and tissues. Free Radic Biol Med. 2003 Nov 1;35(9):1138-48. doi: 10.1016/s0891-5849(03)00496-9. — View Citation
Shannon AM, Bouchier-Hayes DJ, Condron CM, Toomey D. Tumour hypoxia, chemotherapeutic resistance and hypoxia-related therapies. Cancer Treat Rev. 2003 Aug;29(4):297-307. doi: 10.1016/s0305-7372(03)00003-3. — View Citation
Swartz 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. — View Citation
Tatum JL, Kelloff GJ, Gillies RJ, Arbeit JM, Brown JM, Chao KS, Chapman JD, Eckelman WC, Fyles AW, Giaccia AJ, Hill RP, Koch CJ, Krishna MC, Krohn KA, Lewis JS, Mason RP, Melillo G, Padhani AR, Powis G, Rajendran JG, Reba R, Robinson SP, Semenza GL, Swartz HM, Vaupel P, Yang D, Croft B, Hoffman J, Liu G, Stone H, Sullivan D. Hypoxia: importance in tumor biology, noninvasive measurement by imaging, and value of its measurement in the management of cancer therapy. Int J Radiat Biol. 2006 Oct;82(10):699-757. doi: 10.1080/09553000601002324. — View Citation
Vaupel 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. — View Citation
Vaupel 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. — View Citation
Vaupel P. Hypoxia and aggressive tumor phenotype: implications for therapy and prognosis. Oncologist. 2008;13 Suppl 3:21-6. doi: 10.1634/theoncologist.13-S3-21. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation | This is a safety study to demonstrate that the OxyChip will be well-tolerated with minimal risk for complications. All tumors will be excised with the OxyChip in place, and histology will be analyzed for signs of tissue reaction and inflammation adjacent to the OxyChip. pathologic findings associated with the OxyChip are reported. | From time of implantation procedure to 2 weeks after removal of OxyChip, up to 18 weeks | |
Primary | Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction) | This is a safety study to demonstrate that the implantation procedure, the OxyChip and any subsequent oxygen measurements will be well-tolerated with minimal risk for complications. | From time of implantation procedure to 2 weeks after removal of OxyChip | |
Secondary | Measurement of Tumor Partial Pressure of Oxygen (pO2) Levels Using the OxyChip Sensor and EPR Oximetry | This study will also determine the feasibility of repeated measurements of pO2 in tumors using the OxyChip and EPR oximetry. Tumor pO2 values will be reported in millimeters of mercury (mmHg).
Two types of measurements (Data) were made: (i) Baseline tumor pO2 values in patients breathing room air during the first up to 10 min period; and (ii) Hyperoxygenation pO2 values at the end of patients breathing 100% oxygen gas for up to 10 min. The hyperoxygenation was administered immediately following the baseline (room-air breathing) measurements. |
From time of implantation procedure to time of OxyChip removal; an average of 2 weeks for Phase IA and up to 4 months for Phase IB | |
Secondary | The Time Required to Complete EPR Oximetry Measurements | This study will also determine the feasibility of repeated measurements of oxygen in tumors using the OxyChip and EPR oximetry. We will determine the workflow and time required for each daily oxygen measurement. The measurement time, averaged over multiple measurements on each patient, will be reported as less than or greater than one hour. | From time of preparing the patient for EPR measurement, for example placement of the patient on the bed, attaching the resonator, to completion of the EPR measurements, for example, detaching the resonator and removing the patient off the bed. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01193595 -
Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT01001221 -
Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor
|
Phase 1/Phase 2 | |
Completed |
NCT01095302 -
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel and Cisplatin in Patients With Solid Tumors
|
Phase 1 | |
Completed |
NCT01021150 -
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Cisplatin in Patients With Solid Tumors
|
Phase 1 | |
Completed |
NCT01087021 -
Effect of Cabazitaxel on the QTc Interval in Cancer Patients
|
Phase 1 | |
Suspended |
NCT00868647 -
Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood
|
Phase 2 | |
Completed |
NCT01063946 -
A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor
|
Phase 1 | |
Terminated |
NCT03321903 -
EPR Tumor Oximetry With CE India Ink
|