Lupus ErythematosusNCT00029926
Positron Emission Tomography (PET) to Locate Areas of White Blood Cell Activity
An observational study of Lupus Erythematosus and Systemic, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
This study will examine whether PET imaging can reveal what is happening in lymph nodes of patients with systemic lupus erythematosus, or lupus, during periods of active disease. Patients may have periods of active disease when they may feel sick with fever, fatigue, and aching or swollen joints. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- 2-deoxy-2 [F-18] fluoro-2-d-glucose
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Nov 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Subjects must be at least 18 years of age at time of entry.
Subjects must have the ability to give written informed consent prior to entry in the protocol.
Subjects must fulfill at least 4 criteria for SLE as defined by the American College of Rheumatology.
Patient's with a body habitus not allowing for PET scanning due to technical reasons (weight exceeding 299 pounds or 136 kg) will be excluded.
Subjects with concurrent diseases that may alter lymphocyte activation (e.g. -sarcoidosis, chronic inflammatory diseases, asthma) will not be eligible.
Pregnant and lactating women will be excluded. Women of childbearing potential are required to have a negative pregnancy test.
Subjects with active severe CNS lupus (encephalopathy, cerebrovascular accident, transverse myelitis, severe depression, psychosis) will be excluded.
Subjects with a history of malignancy or current malignancy with the exception of basal cell carcinoma of the skin will be excluded.
Subjects with viral or acute bacterial infection within 3 weeks of the study will be excluded.
Subjects with an active infection will be excluded.
Subjects with active hepatitis B, hepatitis C or HIV infection will be excluded.
Subjects with generalized lymphadenopathy (more than 3 anatomical regions) will be excluded.
Subjects with diabetes mellitus will be excluded.
Subjects with a splenectomy will be excluded.
Subjects with a poor venous access will be excluded.
Subjects with a SLEDAI (Systemic lupus erythematosus disease activity index) score of greater than 2 and less than 8 will be excluded.
Subjects with a significant concurrent medical condition that, in the opinion of the principal investigator, could affect the patient's ability to tolerate or complete the study will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study of F-18FDG Positron Emission Tomography (PET) to Assess the Distribution of Activated Lymphocytes in Systemic Lupus Erythematosus (SLE)
This study will examine whether PET imaging can reveal what is happening in lymph nodes of patients with systemic lupus erythematosus, or lupus, during periods of active disease. Patients may have periods of active disease when they may feel sick with fever, fatigue, and aching or swollen joints. Their blood tests are abnormal and their kidney, lungs or heart may be affected. At other times, the disease is inactive, and patients feel well, their blood is normal, and there is no evidence of organ disease.
In lupus, like other autoimmune diseases, the body's immune system attacks it own healthy tissues. Activated lymphocytes (a type of immune cell) lead to the production of antibodies and chemical signals that contribute to the disease process. In animals with lupus, these cells are activated in the lymphoid organs, such as the lymph nodes or spleen. It is not known exactly where these cells are activated in humans. Because some lymph nodes are located deep inside the chest and abdomen; surgery is currently the only way to examining them. PET imaging may provide an alternative, non-invasive, means of obtaining information on lymph node activity in humans. This test uses a radioactive sugar molecule called F18-FDG to find areas of increased cellular activity in the body. (Cells use sugar for fuel, so active cells, such as active lymphocytes, uses more FDG than other body tissues.) This study will determine whether PET can detect these areas of increased activity in lupus during active disease.
Read more
Patients with active or inactive lupus may be eligible for this study. Candidates are screened with a history, physical examination, and routine blood and urine tests. Women who are pregnant or breastfeeding may not participate.
Participants will undergo PET scanning. On the day of the scan they have a brief medical history and physical examination and a blood sample is drawn to check blood count and look for markers of lymphocyte activation. Then, a small plastic tube (catheter) is placed into a vein in the patient's arm, the FDG is injected through the catheter, and the patient rests for an hour. For the scan, the patient lies flat in a cradle that is moved into the central hole of the doughnut-shaped PET camera, and pictures are taken over the next 2 hours, with the patient lies quietly, without moving the head or arms. After the scan is finished, the patient empties the bladder approximately every hour for 6 hours to excrete the radioactive sugar.
Read the detailed description
This pilot study aims to evaluate the value of Positron Emission Tomography (PET) in assessing the distribution of activated lymphocytes in SLE patients. Systemic lupus erythematosus (SLE), often defined as the prototypical autoimmune disease, is a chronic occasionally life threatening, multisystem disorder. Determining disease activity in SLE is essential for the selection of appropriate and effective therapeutic regimes. Lymphocyte activation is the hallmark of SLE and correlates well with disease activity. 2-deoxy-2 [F-18] fluoro-2-D-Glucose positron emission scanning (FDG-PET) is a physiologically based method of imaging that provides non-invasive information on uptake and metabolism of glucose in various tissues. Actively metabolizing cells will preferentially take up the radioactively labeled glucose analog and therefore demonstrate increased signal. Actively proliferating lymphocytes take up FDG at a higher rate than resting lymphocytes and are expected to accumulate in selected lymph nodes or spleen that are the anatomic sites of lymphocyte activation. Lymphocyte activation will be confirmed by FACS analysis of circulating lymphocytes.
This study is designed as a single center pilot study with two groups of patients divided into active vs. non-active SLE and both groups will undergo FDG-PET scanning. The primary objective will be to evaluate the feasibility of FDG-PET in assessing distribution of activated lymphocytes in active and inactive SLE patients. The goal is to detect activated lymphocytes at their homing sites and correlate the pattern of distribution with clinical disease activity.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- 2-deoxy-2 [F-18] fluoro-2-d-glucose
- Keywords
- Imaging, Immune System, Autoimmune Disease, Lymphonodes, Spleen, Systemic Lupus Erythematosus, Lupus, SLE
- Medical subject headings
- Autoimmune Diseases, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-deoxy-2 [F-18] fluoro-2-d-glucoseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2002 (estimated)
- Study startJan 2002
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- 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
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029926
- Sponsor's protocol ID
- 020114
- Other IDs
- 02-AR-0114
- Status last verified
- Nov 2002
- First submitted
- 26 Jan 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Jacobson DL, Gange SJ, Rose NR, Graham NM. Epidemiology and estimated population burden of selected autoimmune diseases in the United States. Clin Immunol Immunopathol. 1997 Sep;84(3):223-43. doi: 10.1006/clin.1997.4412.
PubMed 9281381Datta SK. Production of pathogenic antibodies: cognate interactions between autoimmune T and B cells. Lupus. 1998;7(9):591-6. doi: 10.1191/096120398678920703.
PubMed 9884095Demaison C, Chastagner P, Theze J, Zouali M. Somatic diversification in the heavy chain variable region genes expressed by human autoantibodies bearing a lupus-associated nephritogenic anti-DNA idiotype. Proc Natl Acad Sci U S A. 1994 Jan 18;91(2):514-8. doi: 10.1073/pnas.91.2.514.
PubMed 8290556
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of F-18FDG Positron Emission Tomography (PET) to Assess the Distribution of Activated Lymphocytes in Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT00029926
- Acronym / sponsor ID
- 020114
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Imaging, Immune System, Autoimmune Disease, Lymphonodes, Spleen, Systemic Lupus Erythematosus, Lupus, SLE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Jan 2002
- Study completion
- Nov 2002
- First posted
- 28 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether PET imaging can reveal what is happening in lymph nodes of patients with systemic lupus erythematosus, or lupus, during periods of active disease. Patients may have periods of active disease when they may feel sick with fever, fatigue, and aching or swollen joints. Their blood tests are abnormal and their kidney, lungs or heart may be affected. At other times, the disease is inactive, and patients feel well, their blood is normal, and there is no evidence of organ disease.
In lupus, like other autoimmune diseases, the body's immune system attacks it own healthy tissues. Activated lymphocytes (a type of immune cell) lead to the production of antibodies and chemical signals that contribute to the disease process. In animals with lupus, these cells are activated in the lymphoid organs, such as the lymph nodes or spleen. It is not known exactly where these cells are activated in humans. Because some lymph nodes are located deep inside the chest and abdomen; surgery is currently the only way to examining them. PET imaging may provide an alternative, non-invasive, means of obtaining information on lymph node activity in humans. This test uses a radioactive sugar molecule called F18-FDG to find areas of increased cellular activity in the body. (Cells use sugar for fuel, so active cells, such as active lymphocytes, uses more FDG than other body tissues.) This study will determine whether PET can detect these areas of increased activity in lupus during active disease.
Patients with active or inactive lupus may be eligible for this study. Candidates are screened with a history, physical examination, and routine blood and urine tests. Women who are pregnant or breastfeeding may not participate.
Participants will undergo PET scanning. On the day of the scan they have a brief medical history and physical examination and a blood sample is drawn to check blood count and look for markers of lymphocyte activation. Then, a small plastic tube (catheter) is placed into a vein in the patient's arm, the FDG is injected through the catheter, and the patient rests for an hour. For the scan, the patient lies flat in a cradle that is moved into the central hole of the doughnut-shaped PET camera, and pictures are taken over the next 2 hours, with the patient lies quietly, without moving the head or arms. After the scan is finished, the patient empties the bladder approximately every hour for 6 hours to excrete the radioactive sugar.
Detailed description
This pilot study aims to evaluate the value of Positron Emission Tomography (PET) in assessing the distribution of activated lymphocytes in SLE patients. Systemic lupus erythematosus (SLE), often defined as the prototypical autoimmune disease, is a chronic occasionally life threatening, multisystem disorder. Determining disease activity in SLE is essential for the selection of appropriate and effective therapeutic regimes. Lymphocyte activation is the hallmark of SLE and correlates well with disease activity. 2-deoxy-2 [F-18] fluoro-2-D-Glucose positron emission scanning (FDG-PET) is a physiologically based method of imaging that provides non-invasive information on uptake and metabolism of glucose in various tissues. Actively metabolizing cells will preferentially take up the radioactively labeled glucose analog and therefore demonstrate increased signal. Actively proliferating lymphocytes take up FDG at a higher rate than resting lymphocytes and are expected to accumulate in selected lymph nodes or spleen that are the anatomic sites of lymphocyte activation. Lymphocyte activation will be confirmed by FACS analysis of circulating lymphocytes.
This study is designed as a single center pilot study with two groups of patients divided into active vs. non-active SLE and both groups will undergo FDG-PET scanning. The primary objective will be to evaluate the feasibility of FDG-PET in assessing distribution of activated lymphocytes in active and inactive SLE patients. The goal is to detect activated lymphocytes at their homing sites and correlate the pattern of distribution with clinical disease activity.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-deoxy-2 [F-18] fluoro-2-d-glucose | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9281381Jacobson DL, Gange SJ, Rose NR, Graham NM. Epidemiology and estimated population burden of selected autoimmune diseases in the United States. Clin Immunol Immunopathol. 1997 Sep;84(3):223-43. doi: 10.1006/clin.1997.4412.
- Background: PubMed 9884095Datta SK. Production of pathogenic antibodies: cognate interactions between autoimmune T and B cells. Lupus. 1998;7(9):591-6. doi: 10.1191/096120398678920703.
- Background: PubMed 8290556Demaison C, Chastagner P, Theze J, Zouali M. Somatic diversification in the heavy chain variable region genes expressed by human autoantibodies bearing a lupus-associated nephritogenic anti-DNA idiotype. Proc Natl Acad Sci U S A. 1994 Jan 18;91(2):514-8. doi: 10.1073/pnas.91.2.514.
Related trials for Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
Not yet recruitingPhase 2
This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
Cutaneous Lupus Erythematosus (CLE)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus and Systemic, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029926, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.