Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy

• Sponsor: University of Arkansas (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01967927
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 92.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

To estimate the mean and standard deviation (SD) of the post-treatment decreases in the interstitial fluid pressure and hypoxia-specific PET-scan signal from GRID-treated tumors in patients with locally advanced squamous-cell carcinoma of the head and neck.

The possible effects of GRID radiotherapy on tumor oxygenation levels and interstitial fluid pressure within the tumors will be measured by assessing the trend and statistical significance of the difference in values for each condition obtained prior to and just after GRID exposure in each subject enrolled in the study. We expect that there may be a trend for increases in tumor oxygenation and decreases in interstitial fluid pressure which would indicate that more accurately timed additional chemotherapy and radiation therapy would improve overall patient outcomes.

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma of the Head and Neck	Drug: 18F-MISO	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Aug 17, 2021
• Actual Study Completion Date: Aug 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GRID 18F-MISO	Drug: 18F-MISO; A radiolabeled imaging agent that has been used for investigating tumor hypoxia with positron emission tomography (PET).; Other Names: [18F]FMISO [18F]FLUOROMISONIDAZOLE 1H-1-(3-[18F]-FLUORO-2-HYDROXY-PROPYL)-2-NITRO-IMIDAZOLE

Outcome Measures

Primary Outcome Measures

1. To estimate the mean and standard deviation of the decrease in interstitial fluid pressure in tumors within 72 hours after GRID treatment. [within 72 hours after GRID treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 - 80 years of age

• Karnofsky performance status greater than 70 or ECOG ≥ 2

• Cytological or histological documentation of squamous cell carcinoma of the head and neck, including the tongue, with a minimum tumor size of 6cm in any dimension.

• History of adequate hepatic function (endoscopic or percutaneous drainage as needed):

1. AST (SGOT) / ALT (SGPT) ≤ 5X institutional ULN

• Chemotherapy naive

• History of adequate renal and bone marrow function:

1. Leukocytes ≥ 3000/uL

2. ANC ≥ 1500/uL

3. Platelets ≥ 100000/UI

4. Serum Creatinine ≤ 2.0 mg/dL

Exclusion Criteria:

• Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence

• Subjects with active infections such as pneumonia, or wound infections that would preclude study procedures

• Subjects with known presence of central nervous system or brain metastases

• Subjects with prior radiotherapy to the head and neck region

• Subjects will be excluded if deemed unable to comply with study procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72120

Sponsors and Collaborators

• University of Arkansas

Investigators

• Principal Investigator: Robert J Griffin, PhD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT01967927
• Other Study ID Numbers: 138725; 138725
• First Posted: Oct 23, 2013
• Last Update Posted: Aug 19, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by University of Arkansas: carcinoma; cancer; head; neck; otolaryngology
• Additional relevant MeSH terms: Squamous Cell Carcinoma of Head and Neck; Imidazole

Study Results

No Results Posted as of Aug 19, 2021