Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Ovarian Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Vulvar Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Vaginal Diseases

Uterine Cervical Diseases

Uterine Diseases

Ovarian Cancer

Vaginal Cancer

Vulvar Cancer

Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy

Brachytherapy

Xiang Zhang

Jianhong Chen

Yeqiang Tu

Brachytherapy for gynecological cancers will be studied retrospectively.

Retrospective Study of Brachytherapy

A Retrospective Study of Brachytherapy in Gynecological Cancers

the percentage of participants in the group who survives

the percentage of participants in the group whose disease is likely to remain stable

Zhejiang Cancer Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.

Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.

Image guided placement of a fiducial consisting of a needle directed placement of a T-Bar next to the target lesion in order to lead the surgeon to the lung region to be removed

Image guided Video-Assisted Thoracic Surgery (VATS) resection

Standard of Care Video-Assisted Thoracic Surgery (VATS) resection

Video-Assisted Thoracic Surgery

Julianne S Barlow

Raphael Bueno, MD

Julianne Barlow

To evaluate workflow and outcomes of iVATS and standard VATS for small pulmonary nodules. The outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.

This is a prospective phase II clinical study to evaluate iVATS and standard VATS for small pulmonary nodules. We have successfully completed and published a phase I/pilot study with 25 patients demonstrating safety and optimal procedural workflow for combining image-guidance with VATS. This phase II clinical study will further expand upon the safety and feasibility of this procedure. Additionally, this data will be used to design a phase III comparison study between iVATS and standard VATS.

Image Guided VATS vs. VATS Resection

Image Guided VATS Resection vs. VATS Resection of Lung Lesions

To collect imaging data from pre-operative and post-operative CT scans for quantitative analysis from both arm.

The time (in min.) from incision to close

The time from patient ready for surgery to placement of t-bar

Time (in min) from induction to incision made

Length of hospital stay (in days) in both arms

The radiation exposure (mSV) in the iVATS arm

Brigham and Women's Hospital

Chief of Throacic Surgery

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Intervention: Targeted lesion based thermoablation of MRI-visible biopsy proven clinically significant prostate cancer. Ablative effect is aimed to cover lesion with 5 mm MRI based healthy tissue overlap wherever possible but not compromising viability of critical tissues, mainly the wall of rectum.

The technology is developed to ablate targeted prostate tissue through transurethrally inserted probe that transmit ultrasound energy under MRI guidance and control. The therapeutic endpoint of this method is thermal coagulation of prostate tissue.

TULSA-PRO (Profound Medical Inc, Toronto, Canada): PAD-105, integrated into a 3 Tesla MR-system (Ingenia 3.0 Tesla, Philips Healthcare, Best, Netherlands)

MRI-TULSA

Peter Boström, M.D.Ph.D.

Magnetic resonance imaging (MRI) has improved detection of clinically significant prostate cancer (PCa). MRI-guided transurethral ultrasound ablation (MRI-TULSA) system incorporates precise diagnosis and simultaneous ablation of prostate tissue enabling lesion-targeted treatment of PCa. Lesion-based treatment strategy spares surrounding healthy tissues from injury, which may improve the outcome of genitourinary function. This study further investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible biopsy-proven PCa with MRI-TULSA.

Improving diagnostic methods and screening of men with prostate specific antigen (PSA) has led to earlier detection of prostate cancer (PCa) with more favorable disease characteristics. To decrease overtreatment, low risk cases are increasingly treated with active surveillance; nevertheless some of them progress requiring interventions. Intermediate- and high-risk cases need active treatments to improve survival. However, despite desirable local control, the standard therapies including radical prostatectomy and radiation therapy, carry a risk of treatment related adverse effects to genitourinary and bowel functions. There is an eminent need for efficient PCa therapies with minimal effect on genitourinary function and quality of life. To date most studied mini-invasive technologies have used extremities of temperatures to treat PCa including high intensity focused ultrasound and cryoablation.

Magnetic resonance imaging (MRI) has improved PCa diagnosis. Novel MRI techniques enable localization and visualization of clinically significant PCa. Further, MRI can be used for guidance of targeted biopsy from suspicious lesion enhancing detection of clinically significant PCa and pinpointing a target for image guided therapies. Also, increased use of MRI may lead to more MRI-visible tumors encountered in clinical practice developing an unmet need for image guided therapies.

MRI guided transurethral ultrasound ablation (MRI-TULSA) - treatment system offers treatment strategy incorporating precise diagnosis and targeted therapy. It has been evaluated for whole-gland ablation of localized PCa. Further, lesion-targeted MRI-TULSA has been proved to be feasible and safe for treating MRI-visible-biopsy-concordant histologically significant PCa in our phase 1 treat-and-3-week-resect study (not published yet). This current study further investigates the safety and the efficacy of lesion-targeted ablation of MRI-visible biopsy-proven PCa with MRI-TULSA.

Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer

Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-guided Transurethral Ultrasound Ablation for Localized Prostate Cancer

The primary safety outcome is the freedom from severe adverse events over 3 months follow up: Clavien Dindo Classification of surgical complication is graded from 1 (mild) to 5 (death). Severe adverse events are regarded as events graded ≥3.

The primary oncological efficacy outcome, disease free survival (DFS), is the freedom from any histologically proven clinically significant prostate cancer as assessed from both 10-12-core systematic biopsies and MRI-directed 2-4-core in field biopsies at 12 months.

Urinary continence status as measured by Expanded Prostate Cancer Index Composite (EPIC) item 5 ≥ 2 (patient filled and reported outcome measure)

Symptom severity as measured by International Prostate Symptom Score (IPSS) (patient filled and reported outcome measure). Compared to baseline, score change of ≥ 4 is considered clinically significant.

Erectile dysfunction status as measured by International Index of Erectile Function item 2 ≥ 2 (erection firmness sufficient for penetration)(patient filled and reported outcome measure). Not applicable for subject with baseline score \< 2.

Erectile function as measure by International Index of Erectile Function-5 (IIEF-5)(patient filled and reported outcome measure). Compared to baseline, score change of ≥ 4 is considered clinically significant.

Presence of a highly suspicious lesion in treatment field on prostate MRI at 6 or 12 months (Likert suspicion level ≥ 4).

In field (ablated area) biopsy-confirmed histologically viable cancer.

Turku University Hospital

Radiotherapy stent

Jesper Carl, PhD

A new method for localization of the prostate during external beam radiotherapy. The method is based on insertion of a new thermo-expandable Ni-Ti stent. The radiological properties of the stent are used for precise prostate localization during treatment using electronic portal images

Inclusion criteria's in the study were 1) Patients should present with histological verified local or locally advanced PC (stage T2b to T3b, N0, M0; UICC 1992 classification was used). 2) Patients should consequently be candidates for intended curative radiotherapy. Prostatic work up is done before inclusion in the study. A new prostatic Nickel - Titanium stent is placed in the prostatic urethra one week prior to the radiotherapy planning CT using a flexible cystoscope to insert the stent under urethral anaesthesia. The stent is then flushed with hot water (60 degrees Celsius). The hot water expands the stent collar, thereby locking the stent in place. Correct positioning of the stent is secured visually on retraction of the scope. Radiotherapy of prostate is given to a mean dose of 70 (department standard regime). Treatment are given with daily fractions of 2 Gy using a combination of 6 MV and 18 MV X-ray fields using isocentric 3D conformal treatment plan, consisting of three MLC conformal radiation fields (One anterior and two lateral wedged fields). This was assumed to be the optimal treatment plan. A pair of orthogonal 15 cm x 15 cm isocenter setup fields was added to the plan. The orthogonal fields are used to obtain pairs of electronic portal images. Electronic portal images are recorded using a Varian As500 electronic portal imaging device (EPID). The images are used to determine the 3D reference position of the stent. The image pairs of the stent were taken at eight treatment sessions in each patient (Session number 1,2,3,6,11,21,22 and 23). From each orthogonal set of images the 3D position of both the stent and the symphysis (pubic bone) are determined. Positions are calculated using orthogonal reconstruction. A control CT scan is made before treatment session number 21 to verify the intra prostatic position of the stent. The intra prostatic position of the stent is also verified during removal of the stent three months after radiation therapy. Before removal the stent was flushed with water at 10 degrees Celsius. When cooled with 10°C cold water, the stent became super soft, and can easily be removed as a twisted wire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Retrospective Study of Brachytherapy	NCT05242861	Brachytherapy Uterine Cervica... Uterine Neoplas... Vulvar Cancer Vaginal Cancer Ovarian Neoplas... Gynecologic Neo...	Brachytherapy	18 Years - 80 Years	Zhejiang Cancer Hospital
Image Guided VATS vs. VATS Resection	NCT03623958	Lung Cancer	Image guided Vi... Video-Assisted ...	18 Years -	Brigham and Women's Hospital
Image Guided VATS vs. VATS Resection	NCT03623958	Lung Cancer	Image guided Vi... Video-Assisted ...	18 Years -	Brigham and Women's Hospital
Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer	NCT03814252	Localized Prost...	MRI-TULSA	18 Years - 95 Years	Turku University Hospital
Prostate Localization During Radiotherapy Using a Ni-Ti Stent and Electronic Portal Imaging - Protocol II	NCT00250224	Prostatic Neopl...	Radiotherapy st...	-	Aalborg University Hospital
Retrospective Study of Brachytherapy	NCT05242861	Brachytherapy Uterine Cervica... Uterine Neoplas... Vulvar Cancer Vaginal Cancer Ovarian Neoplas... Gynecologic Neo...	Brachytherapy	18 Years - 80 Years	Zhejiang Cancer Hospital

Spots Global Cancer Trial Database for image guided

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