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

Studies

Study First Submitted Date 2020-03-02
Study First Posted Date 2020-04-28
Last Update Posted Date 2023-07-03
Start Month Year June 1, 2024
Primary Completion Month Year July 1, 2025
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-07-03

Facilities

Sequence: 201035288
Status Recruiting
Name The University of Alabama at Birmingham
City Birmingham
State Alabama
Zip 35249
Country United States

Facility Contacts

Sequence: 28250899 Sequence: 28250900
Facility Id 201035288 Facility Id 201035288
Contact Type primary Contact Type backup
Name Jonathan McConathy, MD, PhD Name April Riddle, BS RT
Email jmcconathy@uabmc.edu Email ariddle@uabmc.edu
Phone 205-996-7115 Phone 205-934-6504

Facility Investigators

Sequence: 18421645 Sequence: 18421646 Sequence: 18421647 Sequence: 18421648 Sequence: 18421649 Sequence: 18421650 Sequence: 18421651 Sequence: 18421652 Sequence: 18421653 Sequence: 18421654 Sequence: 18421655 Sequence: 18421656 Sequence: 18421657 Sequence: 18421658 Sequence: 18421659
Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288 Facility Id 201035288
Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Principal Investigator
Name Pradeep Bhambhvani, MD Name Gagandeep Choudhary, MD Name Jeffers Charlotte Denise, RPh Name Lapi Suzanne, PhD Name Nabors Burt, MD Name Stringer-Reasor Erica, MD Name Rocque Gabrielle, MD Name Triebel Gerstenecker Kristen, PsyD Name Krontiras Helen, MD Name Falkson Carla, MD Name Nabell Lisle, MD Name Keene Kimberly, MD Name Lancaster Rachel, MD Name Parker Catherine, MD Name Jonathan McConathy, MD, PhD

Conditions

Sequence: 52431158
Name Breast Cancer
Downcase Name breast cancer

Id Information

Sequence: 40343569
Id Source org_study_id
Id Value R20-003

Countries

Sequence: 42775559
Name United States
Removed False

Design Groups

Sequence: 55881748
Group Type Experimental
Title Women with stage 1-4 newly diagnosed breast cancer

Interventions

Sequence: 52740529
Intervention Type Drug
Name [11C]PiB and 18F-labeled DPA-714 PET scan
Description 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.

Design Outcomes

Sequence: 178357510 Sequence: 178357511
Outcome Type primary Outcome Type secondary
Measure Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using PET ligand [F-18]DPA-714. Measure Correlate cognitive testing and self-reporting 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) Time Frame After pre-study visit and before starting chemotherapy
Description Cognitive testing: Hopkins Verbal Learning Test-Revised (HVLT-R), 10/36 Spatial Recall Test Trail Making Test Part A, PASAT Controlled Oral Word Association Test (COWAT) Trail Making Test Part B and the Night Out Task (NOT) Self-report measures: Compensation Strategy Questionnaire (Ecomp) Cognitive Failures Questionnaire HADS Distress Thermometer FACT

Browse Conditions

Sequence: 194475810 Sequence: 194475811 Sequence: 194475812 Sequence: 194475813 Sequence: 194475814 Sequence: 194475815 Sequence: 194475816 Sequence: 194475817 Sequence: 194475818 Sequence: 194475819 Sequence: 194475820 Sequence: 194475821 Sequence: 194475822
Mesh Term Breast Neoplasms Mesh Term Neuroinflammatory Diseases Mesh Term Cognitive Dysfunction Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Breast Diseases Mesh Term Skin Diseases Mesh Term Cognition Disorders Mesh Term Neurocognitive Disorders Mesh Term Mental Disorders Mesh Term Nervous System Diseases Mesh Term Inflammation Mesh Term Pathologic Processes
Downcase Mesh Term breast neoplasms Downcase Mesh Term neuroinflammatory diseases Downcase Mesh Term cognitive dysfunction Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term breast diseases Downcase Mesh Term skin diseases Downcase Mesh Term cognition disorders Downcase Mesh Term neurocognitive disorders Downcase Mesh Term mental disorders Downcase Mesh Term nervous system diseases Downcase Mesh Term inflammation Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48560107
Agency Class OTHER
Lead Or Collaborator lead
Name University of Alabama at Birmingham

Central Contacts

Sequence: 12076951 Sequence: 12076952
Contact Type primary Contact Type backup
Name Jonathan McConathy, MD, PhD Name April Riddle, BS RT
Phone 205-996-7115 Phone 205-934-6504
Email jmcconathy@uabmc.edu Email ariddle@uabmc.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 68504653
Design Group Id 55881748
Intervention Id 52740529

Eligibilities

Sequence: 30914436
Gender Female
Minimum Age 50 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria: 50 years of age or older Female gender Newly diagnosed treatment naïve women with breast cancer that meet the following criteria: Stage IIA: Any 1 of these conditions: There is no evidence of a tumor in the breast, but the cancer has spread to 1 to 3 axillary lymph nodes. It has no spread to distant parts of the body. (T0, N1, M0). The tumor is 20mm or smaller and has spread to the axillary lymph nodes (T1, N1, M0). The tumor is larger then 20mm but not larger than 50mm and has not spread to the axillary lymph nodes (T2, N1, M0). Stage IIB: Either of these conditions: The tumor is larger than 20mm but not larger then 50mm and had spread to 1 to 3 axillary lymph nodes (T2, N1, M0). The tumor is larger than 50mm but has not spread to the axillary lymph nodes (T3, N0, M0). StageIIIA: 1.The cancer of any size has spread to 4 to 9 axillary lymph nodes or to internal mammary lymph nodes. It has not spread to other parts of the body (T0, T1, T2, N2, M0). Stage IIIA may also be a tumor larger than 50mm that has spread to 1 to 3 axillary lymph nodes (T3, N1, M0). 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 either a taxane or an anthracycline drug Exclusion Criteria: Contraindication to PET/MRI, including claustrophobia Pregnancy Lactation Individuals who are unable to participate in the imaging portion due to severity of their medical condition Chronic infectious disease (e.g. HIV, HCV) Chronic inflammatory disease (e.g., fibromyalgia, MS, etc) or autoimmune disease Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation Blood or blood clotting disorder Cancer that has metastasized to the brain Positive urine β-hCG test day of procedure or a serum hCG test within 48 hours prior to the administration of [18F]DPA-714 and [11C]PiB. Currently enrolled in a clinical trial utilizing experimental therapies. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971. Prior brain tumor or other neurological condition known to affect cognition A diagnosis of dementia unrelated to cancer or an adjusted MMSE score < 24
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254178268
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 50
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30660127
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Diagnostic
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 29026806
Responsible Party Type Principal Investigator
Name Jonathan E McConathy
Title M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics
Affiliation University of Alabama at Birmingham