NCT00026793

Assessment of Blood Vessel Density in Kaposi's Sarcoma Lesions

Completed Results posted Last updated 8 July 2020

What this trial tests

trial in Kaposi's Sarcoma in 29 participants. Completed in 20 December 2017.

Timeline

23 April 2001

Primary endpoint
20 December 2017

20 December 2017

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	29
Start date	23 April 2001
Primary completion	20 December 2017
Estimated completion	20 December 2017
Sites	1 location across United States

Conditions studied

• Kaposi's Sarcoma — all drugs for Kaposi's Sarcoma →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 100, any sex, with Kaposi's Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Preliminary Assessment of the Temperature of Kaposi's Sarcoma Lesions Compared to the Temperature in the Normal Skin Measured With Thermography Primary · Baseline (prior to therapy)

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).

Group	Value	95% CI
Kaposi's Sarcoma	1.1	-0.68 – 3.43

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

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.

Group	Value	95% CI
Kaposi's Sarcoma	66	-44 – 451

Preliminary Assessment of the Temperature Change in Kaposi Sarcoma Lesions at Week 18 of Therapy Compared to Baseline as Measured With Thermography Secondary · Baseline and 18 weeks after therapy

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.

Group	Value	95% CI
Kaposi's Sarcoma	-0.985	-2.99 – 0.4

Preliminary Assessment of the Change in Blood Velocity in Kaposi's Sarcoma Lesions Measured With Laser Doppler Imaging Before and After Therapy Secondary · Baseline and 18 weeks after therapy

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.

Group	Value	95% CI
Kaposi's Sarcoma	-115	-305 – -17

Number of Participants With Serious and Non-serious Adverse Events Secondary · Date treatment consent signed to date off study, approximately 196 months and 19 days.

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

Group	Value	95% CI
Kaposi's Sarcoma	0

Sponsor's own description

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.

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Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.