Oxygen Measurements in Subcutaneous Tumors by EPR Oximetry Using OxyChip

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.

Inclusion Criteria:

1. Phase IA: Any tumor identified on imaging or through physical examination 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 systemic
therapy or radiotherapy prior to resection. The tumor must be sufficiently large to
accommodate the OxyChip.

3. Tumor must be present within 3 cm of the surface of the skin.

4. Subject must be capable of giving informed consent or has an acceptable surrogate
capable of giving consent on behalf of the subject.

5. Anticipated time between implantation and planned surgical excision of at least three
days.

Exclusion Criteria:

1. Pregnancy.

2. Receipt of concurrent systemic therapy and radiotherapy, or planned sequential
systemic therapy and radiotherapy, prior to resection (Phase 1B).

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.