Assessment of Blood Vessel Density in Kaposi's Sarcoma Lesions

NCT00026793 | Completed Results

• 2 other identifiers: 01015801-C-0158
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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. ...

Conditions

Kaposi's Sarcoma

Keywords

Kaposi Sarcoma; Doppler; Infrared; HIV; Imaging; Kaposi's Sarcoma; Laser Imaging; Infrared Imaging

Outcome Measures

Primary Outcomes (1)

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

  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).

  Baseline (prior to therapy)

Secondary Outcomes (4)

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

  Baseline (prior to therapy)

• Preliminary Assessment of the Temperature Change in Kaposi Sarcoma Lesions at Week 18 of Therapy Compared to Baseline as Measured With Thermography

  Baseline and 18 weeks after therapy

• Preliminary Assessment of the Change in Blood Velocity in Kaposi's Sarcoma Lesions Measured With Laser Doppler Imaging Before and After Therapy

  Baseline and 18 weeks after therapy

• Number of Participants With Serious and Non-serious Adverse Events

  Date treatment consent signed to date off study, approximately 196 months and 19 days.

Study Arms (1)

Kaposi's Sarcoma

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject selection will primarily be from patients with Kaposi's Sarcoma enrolled on other protocols in the human immunodeficiency virus (HIV) and Acquired immunodeficiency syndrome (AIDS) Malignancy Branch. Other sources will be referrals from other institutes and physicians.

You may qualify if:

• Biopsy proven Kaposi's sarcoma involving the skin or mucosa.
• Age greater than or equal to 18 years.

You may not qualify if:

• Unable or unwilling to give informed consent.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Ensoli B, Nakamura S, Salahuddin SZ, Biberfeld P, Larsson L, Beaver B, Wong-Staal F, Gallo RC. AIDS-Kaposi's sarcoma-derived cells express cytokines with autocrine and paracrine growth effects. Science. 1989 Jan 13;243(4888):223-6. doi: 10.1126/science.2643161.

  PMID: 2643161 BACKGROUND

• Miles SA, Rezai AR, Salazar-Gonzalez JF, Vander Meyden M, Stevens RH, Logan DM, Mitsuyasu RT, Taga T, Hirano T, Kishimoto T, et al. AIDS Kaposi sarcoma-derived cells produce and respond to interleukin 6. Proc Natl Acad Sci U S A. 1990 Jun;87(11):4068-72. doi: 10.1073/pnas.87.11.4068.

  PMID: 1693429 BACKGROUND

• Friedlander M, Brooks PC, Shaffer RW, Kincaid CM, Varner JA, Cheresh DA. Definition of two angiogenic pathways by distinct alpha v integrins. Science. 1995 Dec 1;270(5241):1500-2. doi: 10.1126/science.270.5241.1500.

  PMID: 7491498 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Sarcoma, Kaposi

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Results Point of Contact

• Title: Dr. Robert Yarchoan
• Organization: National Cancer Institute

robert.yarchoan@nih.gov

240-760-6075

Study Officials

• Robert Yarchoan, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2001
• First Posted: November 15, 2001
• Study Start: April 23, 2001
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: July 8, 2020
• Results First Posted: July 8, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)