Prospective Evaluation of Diagnostic Performance of PanTum Detect Test in Adult Patients with Suspected or Confirmed Macroscopic Solid Pre-malignant or Malignant Lesion Referred to FDG PET/CT and in Healthy Adults: Interim Analysis of the PanTumPET Study

Abstract Background Multi-cancer early detection (MCED) blood tests combined with FDG PET/CT may represent a new approach to cancer screening; however, its performances need to be assessed. Aim The aim of the PanTumPET study (NCT06842615) is to prospectively evaluate the diagnostic performance of MCED blood PanTum Detect test of the markers Apo10 + TKTL in adult patients with suspected or confirmed macroscopic solid pre-malignant or malignant lesion(s) who were referred to FDG PET/CT (Group A) and in a healthy adult population (Group B). Results In this interim analysis, the data of first prospectively included subjects from Group A (n = 22) and B (n = 22) were analysed. The presence of pre-malignant or malignant lesion was confirmed in 21/22 cases in Group A and 1/22 cases in Group B. With a threshold value of sum-score Apo10 + TKTL ≥ 260. the sensitivity, specificity and diagnostic accuracy were 13/22 (59%), 20/22 (91%) and 33/44 (75%), respectively. With the proposed semiquantitative-Bory (SB) sum-score (sum-score Apo10 + TKTL1 score ≥ 260: score 3, sum-score Apo10 + TKTL1 ≥ 255 and ≤ 259: score 2, Apo10 score ≥ 140: score 2, TKTL1 score ≥ 120: score 1), the sensitivity, specificity and diagnostic accuracy were 18/22 (82%), 18/22 (82%) and 37/44 (84%), respectively. FDG PET/CT was available in 22/22 cases in Group A and 2/22 cases in Group B. FDG PET/CT showed ≥ 1 FDG avid focus in 20/22 (91%) cases with confirmed pre-malignant or malignant lesions. Conclusion Interim analysis of PanTumPET study of the performance of the PanTum Detect test is encouraging for continuation of the study. The overall diagnostic accuracy of proposed SB sum-score was significantly higher than the criteria proposed by previous published works and needs to be further evaluated.