EPR Tumor Oximetry With CE India Ink

NCT03321903 | Terminated DMC

• 2 other identifiers: 29880 D17008P01CA190193
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

It has been well established that malignant tumors tend to have low levels of oxygen and that tumors with very low levels of oxygen are more resistant to radiotherapy and other treatments, such as chemotherapy and immunotherapy. Previous attempts to improve response to therapy by increasing the oxygen level of tissues have had disappointing results and collectively have not led to changing clinical practice. Without a method to measure oxygen levels in tumors or the ability to monitor over time whether tumors are responding to methods to increase oxygen during therapy, clinician's reluctance to use oxygen therapy in usual practice is not surprising. The hypothesis underlying this research is that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, including combined therapy, and to minimize normal tissue side effects or complications. Because studies have found that tumors vary both in their initial levels of oxygen and exhibit changing patterns during growth and treatment, we propose to monitor oxygen levels in tumors and their responsiveness to hyperoxygenation procedures. Such knowledge about oxygen levels in tumor tissues and their responsiveness to hyper-oxygenation could potentially be used to select subjects for particular types of treatment, or otherwise to adjust routine care for patients known to have hypoxic but unresponsive tumors in order to improve their outcomes. The overall objectives of this study are to establish the clinical feasibility and efficacy of using in vivo electron paramagnetic resonance (EPR) oximetry-a technique related to magnetic resonance imaging (MRI)-to obtain direct and repeated measurements of clinically useful information about tumor tissue oxygenation in specific groups of subjects with the same types of tumors, and to establish the clinical feasibility and efficacy of using inhalation of enriched oxygen to gain additional clinically useful information about responsiveness of tumors to hyper-oxygenation. Two devices are used: a paramagnetic charcoal suspension (Carlo Erba India ink) and in vivo EPR oximetry to assess oxygen levels. The ink is injected and becomes permanent in the tissue at the site of injection unless removed; thereafter, the in vivo oximetry measurements are noninvasive and can be repeated indefinitely.

Conditions

Neoplasms, Malignant; Breast Neoplasm; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Melanoma; Skin Neoplasm; Head and Neck Neoplasms

Keywords

Oxygen; Oximetry; Electron Spin Resonance Spectroscopy; Carbon; Charcoal; Radiotherapy; India Ink; EPR; ESR; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Measurement of oxygen levels in tissues in response to hyperoxic therapy

  This study will assess whether the addition of hyperoxic therapy (100% oxygen delivered through a non-rebreather face mask) will increase the oxygen level of a tumor or tumor bed by \> 5 mm Hg using EPR oximetry. Tumor oxygen values will be reported in millimeters of mercury (mmHg).

  From time of ink injection to the time the ink is removed through surgical resection. This can range from days to years, or until the study's completion of enrollment, anticipated in 2020.

Secondary Outcomes (4)

• Characterize oxygen changes in tumor beds throughout the course of radiation therapy

  From time of ink injection through the completion of radiation therapy; an average of 4 months.

• Characterize oxygen changes in tumors throughout the course of radiation therapy

  From time of ink injection through the completion of radiation therapy; an average of 4 months.

• Characterize oxygen changes in tumor and tumor beds prior to radiation therapy

  From time of ink injection through the completion of medical treatment for cancer; an average of 4 months.

• Characterize oxygen changes in tumor and tumor beds through the course of radiation therapy

  From time of ink injection through the completion of medical treatment for cancer; an average of 6 months.

Other Outcomes (1)

• Tissue Histology

  Approximately 30 days post-surgical excision of the tumor

Study Arms (4)

1: Intraoral Squamous Cell Carcinomas

Intraoral squamous cell carcinomas that are resected and receive adjuvant radiation therapy. These patients may receive a Carlo Erba Ink injection before surgical tumor resection, after tumor resection (in the postsurgical radiation field), or in both instances. Patients whose tumor is within 5 mm of the surface will have injections of India ink into the tumor itself and measurements made in the tumor prior to surgery. Patients whose tumor is deeper than 5 mm of the surface could participate only in the measurements of the postsurgical radiation field. EPR Oximetry measurements will be made in the tumor and/or, if applicable, over the course of radiation in the postsurgical radiation field as appropriate.

Device: Carlo Erba Ink Injection; Other: EPR Oximetry Measurement

2: Cutaneous Malignant Tumors

Patients with primary cutaneous malignant tumors (including but not limited to squamous cell carcinoma, basal cell carcinoma, or melanoma) whose tumor is within 5 mm of the surface and whose treatment plan includes surgical resection and/or postsurgical radiation therapy. These patients may receive a Carlo Erba Ink injection before surgical tumor resection, after tumor resection (in the postsurgical radiation field), in both the tumor and the postsurgical radiation field, or in the tumor prior to radiation therapy. EPR Oximetry measurements will be made in the tumor and/or, if applicable, over the course of radiation in the tumor or postsurgical radiation field as appropriate.

Device: Carlo Erba Ink Injection; Other: EPR Oximetry Measurement

3: Breast Cancers

Breast cancer patients whose treatment plan includes surgical resection followed by radiation therapy. All patients who receive a surgical resection will receive a Carlo Erba Ink injection in the radiation field after sufficient healing has occurred to the area to be injected, as determined in consultation with the treating physicians, and using topical anesthetic or local anesthetic, if the patient so desires. All patients in this cohort will be expected to agree to a minimum of one EPR Oximetry measurement in the planned radiation field prior to radiation and a minimum of one measurement made over the course of radiation therapy.

Device: Carlo Erba Ink Injection; Other: EPR Oximetry Measurement

4: Other tumors

Other tumors within 5 mm of the surface, whose planned treatment includes radiotherapy of the tumor and does not include a planned resection of the tumor. As these other qualifying malignancies are expected to occur only rarely, they will be grouped into a single cohort despite potential varied histology. These patients will receive a Carlo Erba Ink injection in their tumor prior to radiation therapy. All patients in this cohort will be expected to agree to a minimum of one EPR Oximetry measurement in the planned radiation field prior to radiation and a minimum of one measurement made over the course of radiation therapy.

Device: Carlo Erba Ink Injection; Other: EPR Oximetry Measurement

Interventions

Carlo Erba Ink Injection DEVICE

Carlo Erba India ink is used in this study as a paramagnetic oxygen sensor that is injected into tissue, and which, when measured using EPR Oximetry, can provide sensitive, repeated, and direct measurements of tissue oxygen. Each study participant will receive at least one ink injection of 20-50µL of Carlo Erba India Ink. The ink injection will occur within 5mm of the body surface (i.e., skin or mucosa), and may be injected into tumor, postsurgical field of radiation, and/or adjacent normal tissue. Carlo Erba Ink is an aqueous suspension composed of charcoal powder, water for injection, and a suspending agent. Carlo Erba is the name of the manufacturer that supplies the charcoal.

Also known as: Carbon particulate suspension, Charcoal suspension

1: Intraoral Squamous Cell Carcinomas; 2: Cutaneous Malignant Tumors; 3: Breast Cancers; 4: Other tumors

EPR Oximetry Measurement OTHER

An oximetry measurement visit consists of \~ 30 minutes of continuous scans of tissue oxygen in vivo, using an oxygen sensor (i.e., India ink) injected into the tumor that is noninvasively scanned using EPR oximetry. Scans, converted into measurements of pO2, characterize the current tumor oxygen level at: (1) 'steady state' (while breathing room air), 2) response to hyperoxygenation therapy (inhaling oxygen-enriched air for 10 min), and 3) response to resuming inhaling room air. EPR measurements are repeated noninvasively throughout radiation or chemotherapy, to examine changes. The minimum number of visits depends on the patient's cohort; all may have additional measurements. If the ink injection is not surgically removed, EPR oximetry measurements can be repeated indefinitely.

Also known as: Oxygen measurement, oximetry measurement

1: Intraoral Squamous Cell Carcinomas; 2: Cutaneous Malignant Tumors; 3: Breast Cancers; 4: Other tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients with eligible tumors within 5mm of the surface, or that will be receiving postsurgical radiation following the resection of eligible tumors.

You may qualify if:

• Subject must be capable of giving informed consent or has an acceptable surrogate capable of giving consent on behalf of the subject.
• Subject has an eligible tumor that is within 5 mm of the surface (either skin or mucosa) or has had a tumor removed with a tumor bed that is within 5 mm of the surface.
• Eligible tumors types:
• Intraoral tumors: squamous cell carcinoma (SCC), melanoma;
• Primary cutaneous tumors (including, but not limited to): SCC, basal cell carcinoma (BCC,) melanoma;
• Breast malignancies post surgery;
• Other tumors: any tumor within 5 mm of the surface and with planned radiation therapy.

You may not qualify if:

• Previous adverse reaction to a charcoal product e.g., a local hypersensitive response from a black tattoo or from ingestion of activated charcoal
• Previous adverse reaction to the suspending agent
• Subject has a pacemaker that is not known to be MRI compatible
• Subject has a non-removable implant or device with metal that is not known to be MRI compatible
• Subject is pregnant or has a likelihood for becoming pregnant during the basic study timeframe.
• Note: There is no known harm to the woman or her fetus from participating; this is precautionary only.

Sponsors & Collaborators

• Philip Schaner: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

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Biospecimen

Retention: SAMPLES WITHOUT DNA

If the India ink tattoo site is surgically excised as part of standard care for the treatment of the tumor, molecular tests may be performed on the excised tissue surrounding the ink injection site to analyze for molecular biomarkers related to hypoxia, angiogenesis, and tumor growth. The tissue analysis will explore the potential for any identifying biomarkers of the tumor that predict or otherwise are associated with variation in tumor growth or responsiveness to therapy. Subjects may choose to opt of this portion of the study.

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Melanoma; Skin Neoplasms; Head and Neck Neoplasms; Anthrax

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplasms, Squamous Cell; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Philip E Schaner, M.D., Ph.D.

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., Associate Professor of Medicine, Geisel School of Medicine at Dartmouth

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 26, 2017
• Study Start: August 30, 2017
• Primary Completion: October 27, 2019
• Study Completion: October 27, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Locations

US (1)