Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Uterine Cervical Neoplasms

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

Hematinics

All Drugs and Chemicals

Liver Extracts

43 cases received preoperative intravenous injection of indocyanine green and radical resection of q-mc1 cervical cancer under pelvic autonomic nerve fluorescence development

43 cases underwent routine surgery，not indocyanine green injection

ICG retention test and clearance test: intravenous injection, 0.5mg/l. Liver blood flow measurement: intravenous drip, dissolve 25mg ICG in 100ml injection water, and drip at a constant speed for about 50min to make the ICG concentration reach equilibrium.

Indocyanine green

HL Nie

Huilong Nie, Doc.

Indocyanine green was injected intravenously into patients with cervical cancer before operation. The nerve development was observed by infrared imaging system during operation, which was used as the basis for nerve preserving operation of type C cervical cancer. The recovery of bladder function was observed.

This study is an open, randomized and prospective clinical study. 86 patients are planned to be randomly assigned according to 1:1. 43 patients underwent preoperative intravenous injection of indocyanine green, radical resection of q-mc1 cervical cancer under pelvic autonomic nerve fluorescence, and 43 patients underwent routine surgery to observe the medium and long-term urinary system function and pelvic floor function of the subjects.

Before operation, confirm the pathological type, pelvic and abdominal enhancement CT or MRI examination, urography (if necessary), two researchers with senior professional title of gynecology respectively carry out gynecological double diagnosis and triple diagnosis examination, and carry out clinical staging according to figo2018 staging standard; According to NCCN guidelines, subjects who are suitable for radical resection of q-m type C1 cervical cancer (IB1 stage deep interstitial Infiltrator / ib2-iia2 stage) are enrolled for routine preoperative examination, and surgical contraindications are excluded. The operation method is open radical resection of q-m C1 cervical cancer. The same group of researchers with rich experience in gynecological tumor operation act as the chief surgeon. Gradually open the retroperitoneum, walk along the ureter to complete anatomical exposure, observe and record the fluorescence staining degree of pelvic autonomic nerve at different time nodes, and compare with the surrounding blood vessels / lymphatic vessels / adipose tissue, Observe the bladder branch of pelvic visceral nerve, dissociate the pelvic visceral nerve plexus from the rectum uterus / rectocervical ligament, preserve the nerve tissue behind the ureter and bladder, and perform extensive resection.

The shape map of pelvic autonomic nerve (including near-infrared region I and region II) was developed. The researchers recorded the identification of nerve after operation and recorded the best observation time point.

The researchers recorded the operation time, the amount of bleeding, the length of the resected uterosacral ligament, main ligament and bladder cervical ligament, and the distal margin was reserved for nerve staining and quantitative analysis.

Safety observation: allergic reaction, influence on liver and kidney function, influence on hemagglutination state.

Observation of recent indicators of bladder dysfunction after operation: the catheter was removed 1 week after operation, and the residual urine volume was measured by ultrasonography. The catheter was placed again if it was \> 100ml, and then rechecked once a week until the residual urine volume was less than 30ml.

Clinical Study of Indocyanine Green Displaying Pelvic Nerve in Radical Operation of Cervical Cancer

Single Center Clinical Study of Intravenous Indocyanine Green in Pelvic Nerve Visualization During Radical Hysterectomy for Cervical Cancer

Residual urine volume of bladder 7 days after operation

① Micturition time, micturition times, tension urinary incontinence, prolonged micturition time, abdominal pressure micturition, incomplete micturition and dysuria; ② Urodynamic examination, monitoring the maximum urinary flow rate (MFR), average urinary flow rate (AFR), residual urine volume (RU), initial urinary bladder volume (FVS), maximum urinary bladder volume (MVS), detrusor contraction and maximum detrusor contraction force (MDP); ③ Pelvic floor function evaluation: pelvic floor function examination was performed 24 weeks after operation.

Fifth Affiliated Hospital, Sun Yat-Sen University

Infections

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Sarcoma

Acquired Immunodeficiency Syndrome

HIV Infections

Sarcoma, Kaposi

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Communicable Diseases

Herpesviridae Infections

Virus Diseases

DNA Virus Infections

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Kaposi Sarcoma

Antineoplastic Agents

Doxorubicin

Liposomal doxorubicin

Interleukin-12

Adult patients with biopsy-proven cutaneous Kaposi's sarcoma. Some participants received interleukin-12 and liposomal doxorubicin. However, the therapy was administered on a different protocol and was not part of this study.

Robert Yarchoan, M.D.

The purpose of this study is to develop imaging techniques to determine the density of blood vessels and the amount of blood flow in Kaposi s sarcoma (KS) tumors. KS tumors depend on the formation of new blood vessels for their growth. Some experimental therapies for KS are directed at reducing the amount of blood vessels and blood flow in these lesions. Measurement of blood vessel density and blood flow in these lesions could be useful in evaluating the effectiveness of both standard and experimental treatments for this disease.

Patients 18 years of age or older with Kaposi's sarcoma involving the skin may be eligible for this study. Participants will have photographs taken of their lesions and will undergo three imaging procedures (described below) at the beginning of the study (baseline) and then about once every 3 months or so while on the study (up to 2 years) to compare the test results over time. (Imaging may be done at more or less frequent intervals depending on the findings.) A small amount of blood (less than a tablespoon) will be drawn the day of each imaging procedure.

Laser Doppler imaging This technique measures the amount of blood flow in KS lesions by scanning the lesions with a low-power laser beam. Each lesion takes about 3 minutes to scan. The imaging may be done before and after a blood pressure cuff around the arm is inflated for a short time (usually less than 30 seconds).

Multi-spectral imaging This technique uses light to measure the total blood volume in each lesion and how much oxygen is in the blood. Oxygen is carried to the body s cells by a protein in red blood cells called hemoglobin. The light on the multi-spectral imaging instrument is absorbed differently depending on whether the hemoglobin has oxygen attached to it or not. It takes about 2 minutes to scan each lesion.

Infrared thermal imaging This test uses a special camera to take digital infrared pictures of the skin. Images formed of the temperature of the KS lesions are used to assess blood flow in the lesions. This imaging takes about 1 minute per lesion.

...

Background:

Kaposi's sarcoma is a highly vascular tumor. As such, it may provide a good model for the study of angiogenesis-based therapy in cancer. However, there are no standardized techniques now available to assess the effects of anti-angiogenesis therapy on blood flow in KS tissues. The present protocol was written to allow us to explore and gain experience with four promising techniques to examine tumor vasculature in cutaneous KS lesions: a) laser Doppler imaging; b) multi-spectral imaging; c) infrared thermal imaging; and d) optical coherence tomography.

Objectives:

The main objective is to assess, in preliminary fashion, non-invasive methods for studying tumor vascularity and vascular changes in patients with Kaposi's sarcoma using four different imaging techniques. Other objectives are to correlate these techniques to each other and to conventional KS tumor assessment, and to assess the response of these techniques in patients receiving therapy for Kaposi s sarcoma.

Eligibility:

Patients 18 of more years of age with biopsy-proven cutaneous Kaposi's sarcoma involving the skin or mucosa are eligible. They must be willing and able to give informed consent.

Design:

This will be a preliminary study to explore these techniques in Kaposi's sarcoma. Selected Kaposi's sarcoma lesions of patients will be assessed using laser Doppler imaging, multi-spectral imaging, infrared thermal imaging, and optical coherence tomography at entry and then additional time points for up to 4 years. Lesions will also be assessed by conventional measurement and photographs with conventional cameras. In selected patients in which there are Kaposi's sarcoma lesions on the arm, the effects of stopping venous flow for up to 10 seconds will be assessed on the measurements. A complete blood count will be done the day of the measurements. The results of the imaging techniques will be compared with each other, and with conventional tumor assessments. Changes over time will be assessed.

Assessment of Blood Vessel Density in Kaposi's Sarcoma Lesions

Protocol to Assess Vascularity in Kaposi's Sarcoma Lesions Utilizing Non-Invasive Imaging Techniques

Temperature in KS lesions compared to normal skin either adjacent to the lesion or on the contralateral side was measured with thermography (thermal energy). A higher temperature is proportional to the severity of the lesion (worst outcome). A reduction in temperature is consistent with a decrease in severity of the lesions (better outcome).

Blood velocity in Kaposi's Sarcoma lesions as compared to the surrounding area was measured with laser doppler imaging with a low power laser beam. Higher velocity is an indication of more severe lesions.

Temperature in KS lesions compared to normal skin either adjacent to the lesion or on the contralateral side was measured with thermography (thermal energy). A higher temperature is proportional to the severity of the lesion (worst outcome). A reduction in temperature is consistent with a decrease in severity of the lesions (better outcome). The value at week 18 is compared to the baseline value for each subject, and the difference reported.

Blood velocity in Kaposi's Sarcoma lesions as compared to the surrounding area was measured with laser doppler imaging with a low power laser beam. Higher velocity is an indication of more severe lesions. The value at week 18 is compared to the baseline value for each subject, and the difference reported.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

National Cancer Institute (NCI)

Principal Investigator

Kaposi's Sarcoma

Adult patients with biopsy-proven cutaneous Kaposi's sarcoma

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Robert Yarchoan

Only 16/29 participants were analyzed for this outcome measure. Due to the assay being developed, results data were not collected in a consistent manner for the remaining 13 participants.

Preliminary Assessment of the Temperature of Kaposi's Sarcoma Lesions Compared to the Temperature in the Normal Skin Measured With Thermography

Preliminary Assessment of the Blood Velocity in Kaposi's Sarcoma (KS) Lesions Compared to That in the Surrounding Area

Only 10/29 participants were analyzed for this outcome measure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Study of Indocyanine Green Displaying Pelvic Nerve in Radical Operation of Cervical Cancer	NCT05087264	Cervical Carcin...	Indocyanine gre...	18 Years - 75 Years	Fifth Affiliated Hospital, Sun Yat-Sen University
Assessment of Blood Vessel Density in Kaposi's Sarcoma Lesions	NCT00026793	Kaposi's Sarcom...		18 Years - 100 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for infrared imaging