Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

Browse trials for

• Amyloidosis 491

Keywords

• Amyloid
• PET-Positron Emission Tomography
• SUVR-Standard uptake value ratios

Amyloidosis

491 studies on the registry are indexed under Amyloidosis; 135 are open to participants now.

This study's enrollment of 203 is above the median of 40 across 304 interventional studies indexed under Amyloidosis.

Lead sponsor

GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Study arms

• Experimental
  [18F] Flutemetamol

  Drug: [18F] Flutemetamol

Interventions

• Drug[18F] Flutemetamol

  Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.

  Also known as: AH110690

Primary outcomes

1. The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.

   A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants). Blinded visual interpretations of \[18F\]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.

   Time frame: Post flutemetamol administration.

Secondary outcomes

1. Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.

   A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader "N") divided by the (Total number of normal participants). Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images.

   Time frame: Post Flutemetamol administrations

2. Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.

   Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference.

   Time frame: Post flutemetamol administration.

3. Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.

   Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference.

   Time frame: Post flutemetamol administration.

Baseline characteristics

Publications

• Thal DR, Ronisz A, Tousseyn T, Rijal Upadhaya A, Balakrishnan K, Vandenberghe R, Vandenbulcke M, von Arnim CAF, Otto M, Beach TG, Lilja J, Heurling K, Chakrabarty A, Ismail A, Buckley C, Smith APL, Kumar S, Farrar G, Walter J. Different aspects of Alzheimer's disease-related amyloid beta-peptide pathology and their relationship to amyloid positron emission tomography imaging and dementia. Acta Neuropathol Commun. 2019 Nov 14;7(1):178. doi: 10.1186/s40478-019-0837-9. Erratum In: Acta Neuropathol Commun. 2020 Aug 3;8(1):121. doi: 10.1186/s40478-020-01005-5. PubMed 31727169 ↗
• Thal DR, Beach TG, Zanette M, Lilja J, Heurling K, Chakrabarty A, Ismail A, Farrar G, Buckley C, Smith APL. Estimation of amyloid distribution by [18F]flutemetamol PET predicts the neuropathological phase of amyloid beta-protein deposition. Acta Neuropathol. 2018 Oct;136(4):557-567. doi: 10.1007/s00401-018-1897-9. Epub 2018 Aug 19. PubMed 30123935 ↗
• Ikonomovic MD, Buckley CJ, Heurling K, Sherwin P, Jones PA, Zanette M, Mathis CA, Klunk WE, Chakrabarty A, Ironside J, Ismail A, Smith C, Thal DR, Beach TG, Farrar G, Smith AP. Post-mortem histopathology underlying beta-amyloid PET imaging following flutemetamol F 18 injection. Acta Neuropathol Commun. 2016 Dec 12;4(1):130. doi: 10.1186/s40478-016-0399-z. PubMed 27955679 ↗