Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Endometrial Neoplasms

Hyperplasia

Endometrial Hyperplasia

Polyps

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All women who would be offered hysteroscopy guided biopsy as standard of care will be offered ultrasound guided biopsy first.

For women needed a hysteroscopy guided biopsy as part of routine standard of care, women will now receive an ultrasound guided biopsy first

Ultrasound guided biopsy

Diana Marcus, MB BS

Joseph Yazbek

Sadaf Ghaem-Maghami, FRCOG PhD

Jospeh Yazbek, FRCOG

Aim: Assess accuracy of histological diagnosis using ultrasound guided biopsy for women with suspected endometrial cancer (as an alternative to hysteroscopy guided biopsy).

All women presenting to clinic with suspected endometrial cancer will have an internal ultrasound. If the endometrial lining is thickened an endometrial biopsy will be performed. This can sometimes be done in an outpatient clinic, or sometimes a hysteroscopy and biopsy is needed (on a different day). Hysteroscopy guided biopsy has the advantage of enabling the clinician to perform directed biopsies under vision.

Ultrasound guided biopsy is a ubiquitous procedure when used elsewhere in the body however it is not routinely used in this context. It does have the advantage of being easily performed on the same day as the first consultation. In this pilot study we will assess the diagnostic ability and tolerability of ultrasound guided biopsy of women with suspected cancer, as an alternative to hysteroscopy guided biopsy.

Aims: Assess accuracy of histological diagnosis using ultrasound guided biopsy for women with suspected endometrial cancer (as an alternative to hysteroscopy guided biopsy).

Background:

Endometrial cancer is a tumour originating in the endometrium (womb lining); it is the most common gynaecological cancer in the UK. Although routine management for these women does vary, in general a screening test is performed, typically a pelvic (internal) ultrasound to assess the endometrium (womb lining). In cases where the endometrial thickness is above the threshold for investigation - an endometrial biopsy (sampling cells from the womb lining) is indicated. The biopsy can be taken blindly or under scan or hysteroscopic guidance. Hysteroscopy, the insertion of a small camera into the womb to visualise the womb lining allows direct visualization of the cavity. This usually occurs at a separate consultation in an outpatient setting or under general anaesthesia.

In theory an ultrasound-guided biopsy using a very fine Bettocchi forceps could be used instead of hysteroscopy- guided biopsies of the endometrium. The technique of ultrasound-guided biopsy is ubiquitous when used elsewhere in the body. It is frequently used to provide histological diagnosis of pelvic masses, (presumed ovarian origin), both abdominally (scanning of the tummy) and transvaginally (internally). Potentially ultrasound guided biopsies could be used as a cheaper, faster and less painful alternative to a hysteroscopy directed biopsies. This pilot study will be the first to assess the diagnostic ability of ultrasound guided biopsy in the assessment of women with suspected endometrial cancer.

The study:

All women will receive a pelvic (internal) ultrasound as per routine care. If the endometrium (womb lining) is thickened \>4mm on ultrasound they will require an endometrial biopsy. Usually this will be a pipelle. In cases where the pipelle biopsy cannot be performed in clinic due to poor tolerance, insufficient material or focal lesions a hysteroscopy guided biopsy will be required (local or GA).

In this case, the patients will be offered an ultrasound (USS) guided biopsy in the first instance, this will be performed at the same time in clinic. The biopsy will be taken under scan guidance using a very fine forceps such as Bettochi forceps. These forceps are used routinely during hysteroscopy so whilst the instruments are common the application is novel. The biopsy results of this will be sent for standard histology. If the results are inadequate patients will be sent for standard hysteroscopy and biopsy. Patients will also be asked to assess tolerability of the procedure using a visual analogue score.

Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy?

Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy in the Detection of Endometrial Cancer?

Accuracy of histological diagnosis using ultrasound guided biopsy.

Visual analogue score will be given to patients post procedure to assess tolerability of the procedure

Imperial College London

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Anxiety Disorders

Breast Neoplasms

Pain

Breast Diseases

Skin Diseases

Patients randomized to the intervention group will undergo their procedure as standard of care but will wear the Oculus Go Goggles and experience a virtual reality simulation. The simulation is a non-interactive polar theme video.

Patients randomized to the control group will undergo their procedure as standard of care without the use of virtual reality goggles.

Oculus Go is a standalone portable Virtual Reality device that enables the user to immerse in different virtual environments. Non pharmacological technique to reduce pain and anxiety during a procedure.

Oculus Go Virtual Reality Goggles

Drew Epling

To determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast biopsy procedure.

Breast biopsies for patients with abnormal mammograms are required to identify cancerous tissue. Currently this procedure is done with or without a local anesthetic. Patients report anxiety regarding potentially having cancer and the possibility of cancer-related procedures. Different types of biopsies may have different pain and anxiety based on their duration and complexity. This research is designed to determine if VR simulated environment can reduce pain and anxiety.

The aim is to study the efficacy of a virtual environment in reducing pain and procedural anxiety. It is intended for patients undergoing an ultrasound guided breast biopsy procedure that have had an abnormal mammogram. The overall aim is to discover an efficacious nonpharmacologic method to lower pain and anxiety during a standard of care procedure.

The Use of Virtual Reality During Breast Ultrasound-Guided Biopsy Procedures

Empatica E4 watch is a wearable device that collects real-time physiological data. This wristband is equipped with photoplethysmogram sensors for computing Heart Rate (HR). Heart rate will be reported in beats per minute (bpm).

Empatica E4 watch is a wearable device that collects real-time physiological data. The photoplethysmogram sensor from the watch will measure temperature. Temperature will be reported in degrees Celsius.

Empatica E4 watch is a wearable device that collects real-time physiological data. The photoplethysmogram sensor from the watch will measure variation of volume of arterial blood under the skin resulting from the heart cycle computing Blood Volume Pulse (BVP). Blood Volume Pulse will be measured in beats min-1.

The Empatica E4 watch is a wearable device that collects real-time physiological data. The photoplethysmogram skin electrodes from the watch will capture the Galvanic Skin Response (GSR), also named Electrodermal Activity (EDA) and Skin Conductance (SC) or the measure of the continuous variations in the electrical characteristics of the skin. GSR will be reported in units of micro-Siemens (μS).

Pain Measured with the Visual Analog Scale. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The individual will score their pain level by circling a number 0 - 10 both pre-operative and post-operatively. The scale range includes 0-10 scales, with \< 2 =well controlled, 2 - 5: partly controlled, \> 5: uncontrolled.

The State-Trait Anxiety Inventory uses a 4 point Likert scale to assess how much worry, tension or apprehension the subject experiences in his or her present circumstances (state anxiety) and how much anxiety represent a personality characteristic (trait anxiety). Items emphasize the frequency of particular symptoms (ranging from 1 = not at all to 4 = very much). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

Patients in both groups will be asked to rate their satisfaction with their procedures using a five point likert scale (ranging from 1 = definitely disagree to 5 = definitely agree).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy?	NCT03207126	Endometrial Can... Endometrial Neo... Endometrial Hyp... Endometrial Pol...	Ultrasound guid...	18 Years -	Imperial College London
Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy?	NCT03207126	Endometrial Can... Endometrial Neo... Endometrial Hyp... Endometrial Pol...	Ultrasound guid...	18 Years -	Imperial College London
The Use of Virtual Reality During Breast Ultrasound-Guided Biopsy Procedures	NCT05042999	Breast Neoplasm...	Oculus Go Virtu...	18 Years -	Prisma Health-Upstate

Spots Global Cancer Trial Database for ultrasound guided biopsy