Fluorodeoxyglucose Imaging Studies to Detect Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01672918
First received: August 23, 2012
Last updated: May 3, 2014
Last verified: April 2014
  Purpose

Background:

- Autoimmune lymphoproliferative syndrome (ALPS) is a genetic disorder of the lymph system. People with ALPS often have swollen lymph nodes, especially in the neck and armpit. They also have a much higher risk of developing lymphoma. It is not always easy to determine whether the swollen lymph nodes are caused by ALPS or by lymphoma. Researchers want to see whether different imaging studies can show the difference between ALPS and lymphoma. The studies used will be positron emission tomography (PET) and computed tomography (CT). Researchers will use a drug called fluorodeoxyglucose (FDG) to look at the lymph nodes.

Objectives:

- To see how well imaging studies can distinguish between swollen lymph nodes caused by ALPS or by lymphoma.

Eligibility:

  • Individuals must be 5 years of age or older and enrolled on the National Institutes of Health natural history study of ALPS.
  • Participants should either have lymphoma or have symptoms that suggest possible lymphoma.

Design:

  • Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
  • Participants will have an FDG-PET/CT scan. It will be performed according to standard procedures.
  • If the results of the scan do not show lymphoma, participants will stay on the study for 1 year for clinical follow up. They may have a second FDG-PET/CT scan if there is a change in symptoms. Such changes include further enlargement of lymph nodes, unexplained fevers, or weight loss.
  • If the results of the scan show evidence of new or worsening lymphoma, treatment on this study will end. Further tests based on clinical symptoms, including a lymph node biopsy, may be done under the ALPS natural history study to rule out or make a diagnosis of lymphoma.

Condition
Autoimmune Lymphoproliferative Syndrome
Lymphoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Use of Fluorodeoxyglucose Positron Emission Tomography With Computed Tomography for the Evaluation of Autoimmune Lymphoproliferative Syndrome Lymphadenopathy Suggestive of Lymphoma

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 25
Study Start Date: August 2012
Detailed Description:

The Autoimmune Lymphoproliferative Syndrome (ALPS) is an inherited disorder associated with defective lymphocyte apoptosis, which is clinically characterized by prominent nonmalignant lymphadenopathy, hepatosplenomegaly, and overt autoimmune diseases such as hemolytic anemia, autoimmune thrombocytopenia, and neutropenia. Additionally, ALPS patients have a significantly increased risk of developing non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). The diagnosis of lymphoma is particularly troublesome in ALPS because many ALPS manifestations overlap with clinical features suggestive of lymphoma. Therefore, individuals with ALPS may undergo repeated biopsies during the course of the disease. Fluorodeoxyglucose positron emission tomography combined with computed tomography (FDG-PET/CT) is a noninvasive test that may help us discriminate benign from malignant lymphadenopathy in patients with ALPS.

For patients with ALPS and clinical symptoms suggestive of lymphoma, such as a sudden increase in focal lymphadenopathy and/or systemic B symptoms associated with lymphoma, we want to investigate whether FDG-PET/CT is useful in determining a plan of action by assisting in locating the most active lymph node and determining whether a surgical biopsy is warranted. Under this protocol, FDG-PET/CT scans will be done to rule out lymphoma. A lymph node biopsy may be necessary to determine the pathology of the lymph node and will not be done for research purposes alone.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

To qualify for enrollment, patients must meet all of the following:

  1. Fulfill current criteria for the diagnosis of ALPS, which includes documented chronic nonmalignant lymphadenopathy and/or splenomegaly, and either greater than or equal to 1.5% T-cell receptor alpha/beta+ DNTs in the peripheral blood or confirmed RAS mutation with or without elevated alpha/beta DNTs.
  2. Be enrolled in ALPS natural history protocol #93-I-0063.
  3. Have 1 or more of the following:

    1. Sudden enlargement of at least 1 lymph node or group of lymph nodes over baseline.
    2. Systemic symptoms suspicious for lymphoma (i.e., loss of weight, loss of appetite, fatigue, night sweats, fever, and pruritus).
    3. A histologically proven diagnosis of lymphoma or other malignancy.
  4. Be 5 years of age or older.

EXCLUSION CRITERIA:

Patients will be excluded if any of the following is present:

  1. Concurrent proven infection or inflammatory disease (e.g., sarcoidosis), which itself often shows increased FDG uptake by PET and which could interfere with the interpretation of study results.
  2. Hyperglycemia (regardless of etiology) determined by fasting glucose of > 200 mg/dL
  3. Weight in excess of 400 lb, which will exceed the weight limit for the scanner table.
  4. Pregnancy or breast-feeding. For women of childbearing potential, a negative urine or serum pregnancy test is required within 24 hours prior to an FDG-PET/CT scan.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672918

Contacts
Contact: V. Koneti Rao, M.D. (301) 496-6502 kr191c@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: V. Koneti Rao, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01672918     History of Changes
Other Study ID Numbers: 120184, 12-I-0184
Study First Received: August 23, 2012
Last Updated: May 3, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
PET/CT
Lymphoma
Lymphadenopathy
ALPS

Additional relevant MeSH terms:
Autoimmune Lymphoproliferative Syndrome
Lymphoma
Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Genetic Diseases, Inborn
Autoimmune Diseases

ClinicalTrials.gov processed this record on September 18, 2014