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Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04542603
Recruitment Status : Not yet recruiting
First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan E McConathy, University of Alabama at Birmingham

Brief Summary:
This clinical study will use the small molecule translocator protein (TSPO) ligand, 18F-labeled DPA- 714, to visualize and quantify neuroinflammation in treatment naivete women with stage 1-4 newly diagnosed ovarian cancer (without brain metastases) prior to starting neoadjuvant chemotherapy treatment (baseline) and within a month of completing first 6 cycles of cytotoxic chemotherapy treatment (follow-up). In addition, we will use the well-characterized small molecule PET(Positron Emission Tomography) tracer, 11C-labeled Pittsburgh compound B (PiB) to visualize and quantify the regional brain distribution of pathological amyloid deposition at baseline only. The brain amyloid PET and MRI data acquired through this study will be correlated with cognitive test data, clinical data, genetic testing, and biospecimens collected in this study.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: [11C]PiB and 18F-labeled DPA-714 PET scan Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Ovarian Cancer
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: treatment naivete women with stage 1-4 newly diagnosed ovarian Drug: [11C]PiB and 18F-labeled DPA-714 PET scan
One PET with [11C]PiB and One PET with [18F]DPA-714 before chemotherapy treatment begins. One more PET with [18F]DPA-714 after completion of 3-6 cycles of chemotherapy.




Primary Outcome Measures :
  1. Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using the PET ligand [F-18]DPA-714. [ Time Frame: Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks) ]

Secondary Outcome Measures :
  1. Correlate cognitive impairment before and after beginning cancer therapy with the concentration and regional brain distribution of pathologic amyloid deposition measured with the PET tracer [C-11]PiB prior to beginning therapy. [ Time Frame: Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks) ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 50 years of age or older
  2. Female gender
  3. Newly diagnosed treatment naïve women with stage III/IV epithelial ovarian cancer (without known brain metastases).
  4. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
  5. English is primary language
  6. Planned neoadjuvant chemotherapy with platinum and taxane drugs

Exclusion Criteria:

  1. Contraindication to MRI
  2. Pregnancy
  3. Lactation
  4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition
  5. Chronic infectious disease (e.g. HIV, HCV)
  6. Chronic inflammatory disease (e.g., fibromyalgia, MS, etc) or autoimmune disease
  7. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
  8. Blood or blood clotting disorder
  9. Cancer that has metastasized to the brain
  10. Positive urine hCG test day of procedure or a serum hCG test within 48 hours prior to the administration of [18F]DPA-714 and [11C]PiB.
  11. Currently enrolled in a clinical trial utilizing experimental therapies.
  12. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.
  13. Prior brain tumor or other neurological condition known to affect cognition
  14. A diagnosis of dementia unrelated to cancer or an adjusted MMSE score < 24

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542603


Contacts
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Contact: Jonathan McConathy, MD, PhD 205-996-7115 jmcconathy@uabmc.edu
Contact: April Riddle, BS RT 205-934-6504 ariddle@uabmc.edu

Locations
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United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Contact: April Riddle, BS RT    205-934-6504    ariddle@uabmc.edu   
Contact: For, BS         
Principal Investigator: Jonathan McConathy, MD, PhD         
Sub-Investigator: Kerri Bevis, MD         
Sub-Investigator: Pradeep Bhambhvani, MD         
Sub-Investigator: Gagandeep Choudhary, MD         
Sub-Investigator: Warner Huh         
Sub-Investigator: Charlotte Denise Jeffers, RPh         
Sub-Investigator: Kenneth Kim, MD         
Sub-Investigator: Suzanne Lapi, PhD         
Sub-Investigator: Charles Leath, MD         
Sub-Investigator: Margaret Liang, MD         
Sub-Investigator: L. Burt Nabors, MD         
Sub-Investigator: John Straughn, MD         
Sub-Investigator: Kristen Tribel (Gerstenecker), PsyD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Jonathan McConathy, MD, PhD University of Alabama at Birmingham
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Responsible Party: Jonathan E McConathy, M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics Affiliation: University of Alabama at Birmingham Collaborators:, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04542603    
Other Study ID Numbers: R20-100
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To be determined

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Cognitive Dysfunction
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cognition Disorders
Neurocognitive Disorders
Mental Disorders