Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Hypoxia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Signs and Symptoms, Respiratory

Antineoplastic Agents

All Drugs and Chemicals

Etanidazole

Patients receive EF5 IV over 1-2.5 hours. Beginning 24-55 hours later, patients undergo tumor hypoxia measurement using a polarographic needle electrode and intraoperative tumor measurement before undergoing surgical biopsy or resection.

Laboratory Biomarker Analysis

Therapeutic Conventional Surgery

Tissue Oxygen Measurement

Michael Kelley

This pilot phase II trial studies how well EF5 works in measuring lack of tumor oxygen, hypoxia, in patients with stage I-III non-small cell lung cancer. EF5 may be effective in measuring the lack of oxygen in lung tumors and may allow doctors to plan better treatment.

PRIMARY OBJECTIVES:

I. Assess the frequency and degree of hypoxia as measured by EF5 binding in patients with non-small cell lung cancer.

II. Correlate hypoxia as measured by EF5 binding with potential serum/plasma markers of hypoxia in patients with non-small cell lung cancer.

III. Correlate hypoxia as measured by EF5 binding with tissue markers of hypoxia in patients with non-small cell lung cancer.

IV. Correlate hypoxia as measured by EF5 binding with tumor angiogenesis in patients with non-small cell lung cancer.

V. Correlated hypoxia as measured by EF5 binding with apoptosis in patients with non-small cell lung cancer.

VI. Measure and characterize tumor perfusion in relationship to hypoxia in patients with non-small cell lung cancer.

VII. Correlate tumor perfusion to microvessel density in tumor samples in patients with non-small cell lung cancer.

VIII. Determine the longevity of EF5 adducts in human lung tumors.

OUTLINE:

Patients receive EF5 intravenously (IV) over 1-2.5 hours. Beginning 24-55 hours later, patients undergo tumor hypoxia measurement using a polarographic needle electrode and intraoperative tumor measurement before undergoing surgical biopsy or resection.

After completion of study treatment, patients are followed up for 4-6 weeks.

EF5 in Measuring Tumor Hypoxia in Patients With Stage I-III Non-Small Cell Lung Cancer

Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-small Cell Lung Cancer

Spearman's rank correlation will be used to examine the relationship between hypoxia as measured by EF5 binding with serum markers of hypoxia (vascular endothelial growth factor \[VEGF\], D-Dimer, plasminogen activator inhibitor type 1 \[PAI-1\]).

Spearman's rank correlation will be used to examine the relationship between hypoxia as measured by EF5 binding with tissue markers of hypoxia (hypoxia inducible factor 1 \[HIF-1\] alpha, involucrin).

Spearman's rank correlation will be used to examine the relationship between hypoxia as measured by EF5 binding with tumor perfusion.

National Cancer Institute (NCI)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Adenocarcinoma

Carcinoma, Squamous Cell

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Fluorodeoxyglucose F18

Radiopharmaceuticals

Patients receive \^18F FMISO IV over 1 minute followed by PET scanning. Patients undergo a second \^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior \^18F FDG PET scan as part of their routine clinical management undergo \^18F FDG PET scanning at baseline.

18F-fluoromisonidazole

fluorodeoxyglucose F 18

Undergo \^18F-FMISO and \^18F FDG PET scan

positron emission tomography

Undergo \^18 F FMISO PET and \^18F FDG PET

tissue oxygen measurement

Joseph Rajendran

This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Diagnostic procedures using positron emission tomography (PET scan), fluoromisonidazole F 18, and fludeoxyglucose F 18 to find oxygen in tumor cells may help doctors predict how patients will respond to treatment.

PRIMARY OBJECTIVES:

I. Test the extent to which fluoromisonidazole F 18 (\[\^18F\] FMISO) uptake predicts survival of patients undergoing therapy for newly diagnosed stage IB-IVB cervical cancer.

SECONDARY OBJECTIVES:

I. Test \[\^18F\] FMISO tumor uptake as an independent predictor of response to therapy and that it provides additional predictive power over fludeoxyglucose F 18 (\[\^18F\] FDG).

II. Test \[\^18F\] FMISO tumor uptake as a predictor of response in a subgroup of patients receiving radiotherapy.

III. Test the relationship between \[\^18F\] FMISO uptake in the primary tumor and the volume of the primary tumor estimated by CT scan.

IV. Test the reproducibility of \[\^18F\] FMISO uptake in tumors by imaging the same patients on sequential days in a test-retest protocol.

V. Compare \[\^18F\] FMISO PET or PET/CT scan with \[\^18F\] FDG PET or PET/CT scan to test whether \[\^18F\] FMISO is an independent predictor of treatment outcome.

OUTLINE:

Patients receive fluoromisonidazole F 18 (\[\^18F\] FMISO) IV over 1 minute followed by PET scanning. Patients undergo a second \[\^18F\] FMISO PET scan 4-8 weeks later. Patients who have not had a prior fludeoxyglucose F 18 (\[\^18F\] FDG) PET scan as part of their routine clinical management undergo \[\^18F\] FDG PET scanning at baseline. A subset of 10 patients undergo two \[\^18F\] FMISO PET scans within a 48-hour period to evaluate the variability (test-retest) of this imaging measurement.

Patients response to therapy is followed periodically until time to disease progression or for 2 years.

FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Cervical Cancer

Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.

Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.

The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.

The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.

Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols

Patients receive \^18F FMISO IV followed by PET scanning. Patients undergo a second \^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior \^18F FDG PET scan as part of their routine clinical management undergo \^18F FDG PET scanning at baseline.

Diagnostic (^18F FMISO PET and ^18F FDG PET)

Patients receive \^18F FMISO IV followed by PET scanning. Patients undergo a second \^18F FMISO PET scan 4-8 weeks later.

All Patients

Age, Categorical

Gender

United States

Region of Enrollment

Small number of subjects enrolled and events limit meaningful statistical analysis.

Joseph G Rajendran

This outcome is for comparing FMISO Hypoxic Volume to overall survival

This outcome is for comparing FMISO T:Bmax to overall survival

Patients who have not been declared deceased for 2 years after their last FMISO scan.

2 Year Overall Survival

1 patient has been lost to follow up for survival measures.

Overall Survival (OS)

This outcome is for comparison of FMISO Hypoxic Volume to disease-free survival

This outcome is for comarison of FMISO T:Bmax to progression-free survival

Patients who have remained disease-free throughout the 2 year follow up

Disease-Free Survival

Of the 13 patients analyzed for disease-free survival, 10 remained disease-free throughout the 2 year follow up. For 3 patients, we could determine overall survival, but could not confirm whether or not they were disease-free.

Disease-free Survival (DFS)

The correlation between IHC values and FMISO uptake were analyzed using Spearman correlation where p values less than 0.05 were considered significant.

Hif1

VEGF

EGFR

Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.

Patients With IHC Measures

11 tissue samples with Hif1, VEGF, p53 and EGFR IHC values were compared to FMISO uptake.

Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor

11 tissue samples with Ki67 values were compared to FMISO uptake.

Relationship Between Ki67 and Regional FMISO Uptake in Tumor

Patients Who Had Response Determined by Clinical RECIST

PET/CT acquisition was obtained using non-diagnostic low dose CT attenuation scans at the time of PET/CT imaging that limited our ability to accurately measure tumor dimensions and due to lack of complete data, we were not able to fulfill this aim.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
EF5 in Measuring Tumor Hypoxia in Patients With Stage I-III Non-Small Cell Lung Cancer	NCT02154399	Stage IA Non-Sm... Stage IB Non-Sm... Stage IIA Non-S... Stage IIB Non-S... Stage IIIA Non-... Stage IIIB Non-...	EF5 Laboratory Biom... Therapeutic Con... Tissue Oxygen M...	18 Years -	National Cancer Institute (NCI)
FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer	NCT00559377	Cervical Adenoc... Cervical Squamo... Stage IB Cervic... Stage IIA Cervi... Stage IIB Cervi... Stage III Cervi... Stage IVA Cervi... Stage IVB Cervi...	18F-fluoromison... fluorodeoxygluc... positron emissi... tissue oxygen m...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for tissue oxygen measurement