Symptoms and General Pathology

All Conditions

Hypoxia

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.

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.

The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).

OxyChip

Philip E Schaner, M.D., Ph.D.

Periannan Kuppusamy, Ph.D.

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).

This is an early feasibility Phase I clinical trial for safety. The total enrollment for this study is 60 patients (30 per phase). The study is split in a phase IA (short duration of implantation with no other cancer therapy planned prior to excision) and a phase IB (duration of implantation for up to 52 weeks while receiving neoadjuvant radiation therapy or systemic therapy prior to surgical excision), as described below.

The initial 6 patients will have the OxyChip placed for a short duration (up to 4 weeks) after which the OxyChip will be removed when the tumor mass is resected, prior to delivery of any further therapies. After the successful implantation, removal, and evaluation of the OxyChip in the first 6 Phase IA patients, enrollment will be opened to an additional 24 Phase IA patients and to 6 Phase IB patients who will either receive neoadjuvant radiotherapy or systemic therapy (chemotherapy, biologic therapy, or endocrine therapy) while the OxyChip is in place. After the successful implantation, removal, and evaluation of the OxyChip in the first 3 Phase IB patients receiving radiation therapy or systemic therapy, enrollment will be opened to an additional 24 Phase IB patients. Up to five oxygen measurements per week will be made during the course of radiation or systemic therapy. The OxyChips will be removed at surgery. Patients receiving radiation or systemic therapy will be evaluated at least weekly for assessment with respect to any adverse events for the primary objective and oximetry measurements will be taken periodically at least one day after implantation and up to its removal at the planned tumor excision to assess the secondary objective. Following resection, the tissue surrounding the OxyChip will be examined for any adverse events for the primary objective. For the exploratory objectives, the tissue will also be examined for biomarkers associated with hypoxia or growth.

There are two parallel arms of the study; however, the first 6 patients must be in the arm whose tumor will receive no therapy prior to surgical resection. If there are no safety issues, then both arms are open.

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)

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.

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.

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.

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.

National Cancer Institute (NCI)

Periannan Kuppusamy

Scientific Director

Events were evaluated for associated toxicity using the Common Terminology Criteria for Adverse Events (CTCAE);

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.

OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).

IA No Treatment Except Standard-of-care (SOC) Surgery

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.

OxyChip: The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).

IB SOC Adjuvant Therapy and SOC Surgery

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Periannan (Kupps) Kuppusamy MS, PhD

Focal disrupted tissue at edge of tumor with mild nonspecific chronic inflammation

Focal fibrosis, macrophages, and apparent tumor cavitation

Focal organizing fat necrosis

Mild macrophage and foreign body type giant cell reaction at OxyChip site

Mild macrophage predominant chronic inflammatory reaction at needle site

Minimal fat necrosis, macrophage infiltrate immediately surrounding the OxyChip

Minor focal hemorrhage seen adjacent to the deep margin. Very focal collection of macrophages.

Minor hemorrhage at site of injection

Tumor necrosis and mild hemorrhage immediately adjacent to injection site

Tumor necrosis near chip site.

No histologic response seen

Focal fibrosis, a few macrophages adjacent

The OxyChip could not be found for two participants. The chip was presumed to be lost at the time of surgery for one participant and presumed lost prior to surgery due to rapidly progressive tumor necrosis.

Safety of OxyChip by Recording of Adverse Events as Measured by Histological Signs of Tissue Reaction and Inflammation

Discomfort at surgical site

Mild discomfort and bleeding from implantation procedure. Bruising from implantation needle

Mild discomfort from implantation

Minimal bleeding associated with implantation. Mild bruising at needle insertion site

Minor bleeding asociated w implantation. Minor bruising needle ins site. Mild discomfort of L breast

Minor bleeding from implantation needle

Minor bleeding from implantation needle. Mild bruising.

Minor bruising associated with implantation site

No Adverse Events Recorded

Pain and minor bleeding from implantation needle

Pruritis

Pruritis, scalp

Safety of OxyChip by Recording of Adverse Events (Allergic Reaction, Infection, Hemorrhage, Skin Erosion Over the Device, Device Breakage or Malfunction)

Baseline pO2 data

Hyperoxygen pO2 data measured immediately following baseline pO2 data

For Arm 1A, 4 subjects were not measured. For Arm 1B, 4 subjects were not measured.

Measurement of Tumor Partial Pressure of Oxygen (pO2) Levels Using the OxyChip Sensor and EPR Oximetry

One subject from IA had Oxychip presumed lost at time of surgery. 4 subjects from each group were not able to be measured.

The Time Required to Complete EPR Oximetry Measurements

Overall Study

Radiofrequency tumor ablation (RFA) is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.

Radiofrequency ablation (RFA)

Fredric A Hoffer, MD

This is a single-center, Phase II study including only patients on whom a decision to conduct radiofrequency ablation (RFA) has already been made. The primary objective of this study assess if quality of life was improved by RFA as assessed at baseline, 3 and potentially 6 and 12 months following RFA for the benign lesions.

RFA is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using an electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.

RF ablation is an alternative for local tumor control when other treatments (surgery, radiotherapy or chemotherapy) are not feasible (less effective or at higher risk). Thermal ablation at times is the only remaining alternative for patient cure, prolonged survival or palliation. Cryotherapy, and microwave, laser and focused ultrasound are alternative thermal ablation techniques used in adults but there has been no experience in children with these alternative methods.

To be eligible for this study, patients must have acquired lesions at \< 21 years of age (central nervous system lesions are excluded from this study). Study participants will have the RFA procedure performed at Seattle Children's and will have follow-up evaluations at various time points post-RFA.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Oxygen Measurements in Subcutaneous Tumors by EPR Oximetry Using OxyChip	NCT02706197	Neoplasms, Beni... Neoplasms, Mali...	OxyChip	18 Years -	Dartmouth-Hitchcock Medical Center
Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood	NCT00868647	Neoplasms, Beni... Neoplasms, Mali...	Radiofrequency ...	-	Seattle Children's Hospital

Spots Global Cancer Trial Database for neoplasms, benign