Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Examine OCT images and compare them to conventional biopsies in same subject.

Optical Coherence Tomography

Jean Keddissi, MD

Optical coherence tomography will be a feasible adjunct to flexible bronchoscopy, and provide images with good sensitivity and specificity to determine the presence of endobronchial malignancies.

OCT could become a powerful tool in diagnostic pulmonary medicine, not only in the early recognition of lung cancer, but also in the evaluation and monitoring of microstructures in the lower respiratory tract that are affected by other inflammatory or invasive disease processes. Initially, OCT could be used to guide the location of biopsies which would likely provide increased specificity to traditional bronchoscopy. However, if the sensitivity and specificity of OCT images are comparable to histologic specimens, this technology may in the future provide a non-invasive "optical biopsy", which could potentially obviate the need for conventional biopsies in patients with high risks for complications, such as bleeding.

Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer

University of Oklahoma

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Fulvestrant

Estrogens

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Hormones

Hormone Antagonists

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Fluoroestradiol-PET is performed at baseline, after 1 month, and 3 months

A FES-PET/(CT) will be performed thrice during protocol execution. Patients will be injected with \~200MBq 18F-FES

Diagnostic intervention: Positron Emission Tomography with 16-alpha-[18-fluoro]-17betaestradiol

The dose of fulvestrant to optimally downregulate estrogen receptors (ER) is currently subject of debate. Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron emission tomography with the ER-specific FES tracer. In this pilot study we will evaluate the effects of the new dose of fulvestrant (500mg i.m.)on the availability of ER binding sites in 15 metastatic breast cancer patients.

The estrogen receptor (ER) is expressed in approximately 70% of the breast carcinomas. In these patients signaling via the ER induces proliferation and cell survival of malignant cells. Fulvestrant can inhibit this signaling route by blocking the receptor and decreasing ER-expression by increasing its turn-over rate.

The historical standard dose of fulvestrant was 250mg every 28 days i.m.; however studies performing serial biopsies showed that ER-downregulation was suboptimal. Recently the standard dose has been set to 500mg i.m. on day 1; 14; 28 and every 28 days thereafter. Although slightly more effective than the 250mg dose, still questions remain with respect to the required dose to establish maximal downregulation of ER-signaling.

Immunohistochemistry only provides static information, i.e. the level of ER-expression. However, dynamic information evaluating the effects of fulvestrant on occupancy of ERs, may also be valuable.

Whole-body imaging of the availability of ER binding sites using FES-PET may prove valuable to evaluate the effects of fulvestrant on the ER non-invasively in individual patients. This potentially allows adjustment of dosing in individual patients to aid therapy efficacy.

In this pilot-study we will evaluate 15 metastatic breast cancer patients. All patients will undergo FES-PET/CT at baseline, FES-PET after 1 month, and FES-PET/CT after three months. Hormone- and fulvestrant levels will be measured in all patients. Whenever possible, tumor biopsies will be performed to correlate to FES-PET results.

Molecular Imaging of Fulvestrant Effects on Availability of ER Binding Sites

In Vivo Imaging of the Effect of Fulvestrant on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Tumor Lesions Using FES-PET

FES-uptake will be calculated for all tumor lesions at baseline, 1 month and 3 months.

Changes between FES-uptake during fulvestrant therapy will be calculated for:

* 3 months minus baseline
* 3 months minus 1 month
* 1 month minus baseline

FES-uptake will be calculated for all tumor lesions at baseline, after 1 month and after 3 months.

Incomplete down-regulation/ occupancy of ERs is defined as 1) an absolute SUV\> 1.5, and 2) a relative decrease in SUV of \<75% during fulvestrant therapy.

The proportion of patients that match these criteria will be given for:

* 1 month minus baseline
* 3 months minus baseline

Liver metastases detected on PET/CT will be serially quantified at the 3 different time points to evaluate the feasibility to quantify liver lesions on FES-PET/CT

Patients will be categorized as responders and non-responders by standard follow-up (monthly visits, 3-monthly CT, other techniques when indicated).

The predictive value of FES-PET for response to fulvestrant will be calculated for:

* baseline FES-uptake
* changes in FES-uptake from baseline to 1 month
* changes in FES-uptake from baseline to 3 months

Lesion-based evaluation will be performed for measurable lesions as defined by RECIST criteria, and changes in diameter will be correlated to changes in FES-uptake at:

* 1 month minus baseline
* 3 months minus baseline

Explorative analysis to correlate several factors at different timepoints (baseline, 1 month, 3 months) to FES uptake.

University Medical Center Groningen

Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.

Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.

For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.

Unsigned note to provider about cessation medication prescription

Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.

Proactive Telephone Counseling from VA Quitline

Steven B. Zeliadt, PhD MPH

This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.

This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.

Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

The investigators anticipate publishing the findings alongside other similar trials funded by NCI through the Smoking Cessation within the Context of Lung Cancer Screening (SCALE) collaboration, with journals that will likely require concurrent publication of de-identified datasets.

The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records

Provider surveys will assess acceptance of and satisfaction with the proactive care approach among primary care clinicians referring Veterans for lung cancer screening

Costs of implementing the proactive care approach will be monitored and analyzed, including intervention staff effort, provider time, costs of telephone counseling, and pharmacotherapy costs

Patient surveys will assess satisfaction with VA Quitline telephone counseling

Surveys will assess patient motivation to quit smoking

Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective

Surveys will assess patients' self-efficacy for quitting smoking

Fred Hutchinson Cancer Center

VA Office of Research and Development

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

The study scan, s-DCT and correction scan, will be performed within two weeks of the patient's clinical evaluations by chest CT and x-ray. The study scan may be done within 2 weeks prior or two weeks following standard of care imaging. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the standard of care (SOC) imaging and the s-DCT. All patients will have a breath held s-DCT scan in an anterior-posterior direction.

All patients will have a breath held s-DCT scan in an anterior-posterior direction

Scatter corrected s-DCT

Ertan Pamuklar, MD

This is a study that will evaluate the utility of a scatter reduction technique in reducing dose and increasing the sensitivity of stationary digital chest tomosynthesis (s-DCT) in the detection of lung lesions.

Digital tomosynthesis is an imaging modality that produces 3D sectional information using x-ray projections acquired over a limited scanning angle. Scatter is known to be the primary source of image degradation in x-ray based imaging.

The investigators have developed an approach that measures scatter through a low dose (3% of the conventional scan) scatter measurement technique. Preliminary studies have shown that scatter reduction in DCT can significantly improve quality. The approach will characterize the reader confidence in lung nodule detection in a scatter corrected chest tomosynthesis imaging approach as compared to the conventional chest tomosynthesis.

Fifty (50) patients who have undergone a clinical non-contrast CT with lung nodules will be asked to have an s-DCT (scan) within 4 weeks (+/- 2 week) of their clinical CT with no intervening procedures or therapies (i.e. biopsy of lung nodules). Investigators will then perform a reader study to evaluate the radiologist reader confidence in images generated from the scatter reduction technique versus more conventional chest tomosynthesis imaging.

Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Readers will rate their confidence in images from the experimental modality (sDCT with scatter correction) as compared to the conventional scan (chest CT with x-ray) on a 7 point Likert scale (-3 to 3) based on ability to identify lesion(s) present comparing each modality. A value of -3 is significantly less confident in the s-DCT representation 0 is the same confidence in modalities, and 3 is significantly more confident in the s-DCT representation compared to the conventional. Each individual will have a single value per reader. Two readers compared each scan. The overall reader preference between modalities was calculated by determining the mean value.

Sensitivity will be defined as the ability of s-DCT images to detect lesions positively identified on gold standard CT images.

National Cancer Institute (NCI)

UNC Lineberger Comprehensive Cancer Center

The study scan, s-DCT and correction scan, will be performed within two weeks of the patient's clinical evaluations by chest CT and x-ray. The study scan may be done within 2 weeks prior or two weeks following standard of care imaging. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the standard of care (SOC) imaging and the s-DCT. All patients will have a breath held s-DCT scan in an anterior-posterior direction.

Scatter corrected s-DCT: All patients will have a breath held s-DCT scan in an anterior-posterior direction

Scatter Corrected s-DCT

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Director, Clinical Research, Department of Radiology

Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale)

Sensitivity of s-DCT Images (Percentage of Positive Scans)

Overall Study

All enrolled subjects will undergo breast cancer screening with mammography and the MUST device

MUST device

Tejas Mehta, MD

Tejas Mehta, MD, MPH

This is a single-center, pilot study being conducted to evaluate the safety and performance of the investigational device (MUST) in detecting malignant lesions in breast tissue.

This is a single-center, prospective, pilot study in which all enrolled subjects will receive the same screening mammography procedures (i.e., 3D mammography plus MUST).

Subjects will have between 1 and 4 clinic visits. The number of visits will be based upon the mammography and MUST findings, and whether additional procedures, such as MRI, biopsy, or a repeat MUST are warranted.

All enrolled subjects will receive breast cancer screening with mammography and MUST

Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening

A Prospective, Single-Center, Feasibility Study Assessing the Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Identifying Malignant Breast Lesions as an Adjunct to Mammography

Sensitivity of MUST plus mammography versus mammography alone

Specificity of MUST plus mammography versus mammography alone

Assess the sensitivity and specificity by BI-RADS breast density category as determined by the Visit 1 mammogram, for MUST plus mammography vs mammography alone

In the subpopulation of subjects who undergo biopsy, the concordance of MUST with biopsy will be estimated

In the subpopulation of subjects who test positive on mammography (BI-RADS score of 4 or 5) and have a biopsy, sensitivity and specificity will be assessed and compared between MUST and MRI and biopsy results

The co-primary endpoint of overall sensitivity and specificity will be reassessed after subjects have had the opportunity to complete the Month 6 MUST re-evaluation visit, if applicable, and again when all subjects have had the opportunity to complete the Month 12 follow-up phone call to identify events of interval cancer for MUST plus mammography as well as MUST alone

Evaluate the safety of the MUST device by evaluating the adverse event profile

Transonic Imaging, Inc.

Those patients randomized to the mammogram arm will receive a regular 2D mammogram. Compression lasts several seconds in order to obtain 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.

2D Mammogram

Those patients randomized to the tomosynthesis arm will receive a combination of 3D and 2D screening mammogram. The additional tomosynthesis data is obtained immediately after acquisition of the 2D study, with the patient and breast remaining in the same position and compression. Compression lasts about 7 seconds longer for each of the 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.

Tomosynthesis

Aalo Bistritz, MD

Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.

We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped \< 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.

Tomosynthesis in Screening Mammography

A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography

Hologic, Inc.

AHS Cancer Control Alberta

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Stage pT1 and pT2 according to pathology results of patients who underwent partial or radical nephrectomy.

Stage ≥pT3a according to pathology results of patients who underwent partial or radical nephrectomy.

The preoperative imaging of the participants, who were grouped according to the postoperative pathology results, will be examined.

No intervention will be applied.

Selman Unal

The investigators aimed to evaluate the role of some findings that can be detected in preoperative radiological imaging of kidney masses in predicting locally advanced disease.

Renal cell carcinoma (RCC) is one of the most common urinary system cancers and accounts for 3% of all cancers. With the frequent use of imaging methods most renal masses are detected localized. The standard treatment option in localized RCC is radical nephrectomy (RN) or nephron-sparing surgery (NSS). NSS is preferred when appropriate in patients with tumor stage 1 (T1) and has been shown to be comparable to RN in terms of oncologic outcomes. Although there is no prospective randomized study comparing NSS with RN in terms of oncological and renal functions in T2 patients, there are retrospective studies conducted to date. According to the current European urology guideline, the standard approach in patients with T2 and above is RN. Pre-operative clinical staging is performed with computed tomography (CT) or magnetic resonance imaging (MRI), and patients may develop local recurrence despite surgical procedures based on clinical stage. Pre-operative the patient and in the management of local disease. In clinical practice, pre-operative CT and MRI provide information about tumor size, tumor localization, presence of tumor invasion into vascular structures and adjacent organs. However, apart from these frequently reported findings, there are CT and MRI findings that can be used to predict advanced disease. In the 2017 Tumor, node, metastasis (TNM) classification, invasion of the pelvicalyceal system, perirenal or renal sinus fat invasion has been included in the T3a category. There are studies evaluating predictive value of CT to indicate renal sinus fat or perirenal fat invasion. Although not in the standard TNM classification, it has been shown that renal capsule invasion is an independent prognostic variable for advanced disease and can be detected on CT. On the other hand, it has been indicated that thickening of the Gerota's fascia, the presence of enlarged collateral vessels, and the presence of intra-tumoral necrosis may be imaging findings that can be used to predict advanced disease. The investigators think that the markers evaluated so far in pre-operative imaging and some additional markers may predict advanced disease in RCC. The investigators also think that the predictive value of MRI may be higher than CT. Therefore, in this study the investigators evaluated some predictive features (Renal capsule invasion, perirenal fat invasion, thickening of the Gerota's fascia, presence of enlarged collateral vessels, tumor necrosis, perinephric stranding) of pre-operative computed tomography and magnetic resonance imaging for advanced disease in renal cell carcinoma.

Predictive Imaging Features in Renal Cell Carcinoma

Predictive Features of Pre-operative Computed Tomography and Magnetic Resonance Imaging for Advanced Disease in Renal Cell Carcinoma

Whether there was a difference between the two groups in terms of the presence of pre-operative imaging (CT and MRI) renal capsule invasion.

Whether there was a difference between the two groups in terms of the presence of pre-operative imaging (CT and MRI) perirenal fat tissue invasion

Whether there was a difference between the two groups in terms of the presence of pre-operative imaging (CT and MRI) thickening of the Gerota's fascia.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optical Coherence Tomography: An Adjunct to Flexible Bronchoscopy in the Diagnosis of Lung Cancer	NCT01039311	Lung Cancer	Optical Coheren...	18 Years -	University of Oklahoma
Molecular Imaging of Fulvestrant Effects on Availability of ER Binding Sites	NCT01377324	Metastatic Brea...	Diagnostic inte...	18 Years -	University Medical Center Groningen
Molecular Imaging of Fulvestrant Effects on Availability of ER Binding Sites	NCT01377324	Metastatic Brea...	Diagnostic inte...	18 Years -	University Medical Center Groningen
Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment	NCT03612804	Smoking Reducti... Tobacco Use Tobacco Smoking Tomography Lung Diseases Lung Neoplasms	Unsigned note t... Proactive Telep...	- 80 Years	VA Office of Research and Development
Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis	NCT04076696	Pulmonary Nodul... Pulmonary Nodul...	Scatter correct...	18 Years -	UNC Lineberger Comprehensive Cancer Center
Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment	NCT03612804	Smoking Reducti... Tobacco Use Tobacco Smoking Tomography Lung Diseases Lung Neoplasms	Unsigned note t... Proactive Telep...	- 80 Years	VA Office of Research and Development
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening	NCT04102722	Breast Cancer S...	MUST device	40 Years - 74 Years	Transonic Imaging, Inc.
Tomosynthesis in Screening Mammography	NCT01086241	Breast Density ...	2D Mammogram Tomosynthesis	40 Years - 69 Years	AHS Cancer Control Alberta
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening	NCT04102722	Breast Cancer S...	MUST device	40 Years - 74 Years	Transonic Imaging, Inc.
Predictive Imaging Features in Renal Cell Carcinoma	NCT05042089	Renal Malignant...	No intervention...	20 Years - 80 Years	Ankara Yildirim Beyazıt University
Predictive Imaging Features in Renal Cell Carcinoma	NCT05042089	Renal Malignant...	No intervention...	20 Years - 80 Years	Ankara Yildirim Beyazıt University
Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening	NCT04102722	Breast Cancer S...	MUST device	40 Years - 74 Years	Transonic Imaging, Inc.

Spots Global Cancer Trial Database for tomography

Every month we try and update this database with for tomography cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tomography

Every month we try and update this database with for tomography cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tomography cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.