Kaposi's SarcomaNCT00026793
Assessment of Blood Vessel Density in Kaposi's Sarcoma Lesions
An observational study of Kaposi's Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kaposi's Sarcoma
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2001to 20 Dec 2017
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Biopsy proven Kaposi's sarcoma involving the skin or mucosa.
- Age greater than or equal to 18 years.
Who cannot join
- Unable or unwilling to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Protocol to Assess Vascularity in Kaposi's Sarcoma Lesions Utilizing Non-Invasive Imaging Techniques
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.
Read more
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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Read the detailed description
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.
- Conditions
- Kaposi's Sarcoma
- Keywords
- Kaposi Sarcoma, Doppler, Infrared, HIV, Imaging, Kaposi's Sarcoma, Laser Imaging, Infrared Imaging
- Medical subject headings
- Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline and 18 weeks after therapy
Number of Participants With Serious and Non-serious Adverse Events
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.
Measured: Date treatment consent signed to date off study, approximately 196 months and 19 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study start23 Apr 2001
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kaposi's SarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Robert Yarchoan, National Cancer Institute (NCI)
- Investigators
- Robert Yarchoan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026793
- Sponsor's protocol ID
- 010158
- Other IDs
- 01-C-0158
- Status last verified
- Jun 2020
- First submitted
- 14 Nov 2001
- Last updated
- 8 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2643161Miles 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.
PubMed 1693429Friedlander 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.
PubMed 7491498