Prospective Evaluation of Diagnostic Performance of PanTum Detect Test in Adult Patients With Suspected or Confirmed Macroscopic Solid Pre-malignant or Malignant Lesion(s) Referred to Fludeoxyglucose (18F) PET/CT and in Adult Healthy Population

NCT06842615 | Recruiting

• 2 other identifiers: VEGA 1/0394/242024-514272-40-00
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective phase II trial aims to evaluate the diagnostic performance of multi-cancer epitope diagnosis in monocyte (EDIM) based blood test PanTum detect test for early detection of individuals with pre-malignant or malignant lesion(s). The intervention in this trial is the PanTum detect test performed in two parallel groups of participants: Group A: Adult persons

• with suspected or confirmed macroscopic solid pre-malignant or malignant lesion(s) referred to FDG PET/CT
• meeting the inclusion criteria and not-meeting the exclusion criteria
• Expected number of participants: 67 Group B: Healthy adult persons
• meeting inclusion criteria meeting the inclusion criteria and not-meeting the exclusion criteria
• Expected number of participants: 67 Control method: uncontrolled Type of trial: evaluation of diagnostic performance of a diagnostic test with following Primary and Secondary objectives: Primary Objective 1\. To evaluate the sensitivity and specificity of PanTum Detect test in identification of individuals bearing macroscopic solid pre-malignant or malignant lesion(s) Secondary Objectives
• To evaluate the positive and negative predictive value of PanTum Detect test in identification of individuals bearing macroscopic solid pre-malignant or malignant lesion(s)
• To assess the concordance of result of PanTum Detect test with result of FDG PET/CT for macroscopic solid pre-malignant or malignant lesion(s)
• To analyse the most frequent causes of false results of PanTum Detect test
• To analyze the concordance rate of PanTum Detect test No1 and No2
• To refine the interpretation criteria of PanTum Detect test
• To analyse the subject´s willingness to participate on the trial
• To analyse the subject´s experience with participation on the trial

Conditions

Malignant; Pre-malignant

Keywords

macroscopic; solid lesion; pre-malignant; malignant lesion

Outcome Measures

Primary Outcomes (1)

• PanTum test

  To evaluate the sensitivity and specificity of PanTum Detect test in identification of individuals bearing macroscopic solid pre-malignant or malignant lesion(s) Localization of macroscopic solid pre-malignant or malignant lesion(s)

  1st day

Secondary Outcomes (4)

• positive and negative predictive value of PanTum Detect test

  1st day

• concordance of result of PanTum Detect test

  1st day

• false results of PanTum Detect test

  1st day

• concordance rate of PanTum Detect test

  12th month

Study Arms (2)

Cancer Group

EXPERIMENTAL

Group A (Patients with suspected or confirmed macroscopic solid pre-malignant or malignant lesion(s) referred to FDG PET/CT): 30 days for patients with confirmed pre-malignant or malignant lesion(s) and 12 months in patients with suspected pre-malignant or malignant lesion(s) for collection of data from routine clinical workup for collection of data for standard of truth. Reasons for duration of participation in the study: One Pantum detect test is performed in a group of patients with confirmed pre-malignant or malignant lesion(s), at the interval of -30 to 0 or 15-30 days from FDG PET/CT, therefore the duration of inclusion for patients is 1-30 days. However, in case of suspected malignancy and negative FDG PET/CT finding, the collection of data from routine clinical follow-up is necessary to confirm or rule-out the presence of macroscopic solid pre-malignant or malignant lesion(s) and establishment of the standard of truth.

Diagnostic Test: Pantum detect test

Control Group

OTHER

Reasons for duration of participation in the study: Two Pantum detect test are performed in this group: 1. first at the inclusion 2. and the second et the end of 12-month follow-up period Reasons for duration of participation in the study: When PanTum detect test is performed in this group of participants, the probability of positive finding is low however, to exclude the false negative result the non-detection of macroscopic solid pre-malignant or malignant lesion needs to be confirmed by data from routine clinical follow-up during 12 months. At the end of this follow-up period a second PanTum detect test is performed as a part of clinical follow-up to analyse the concordance of the result over the time. In case of detection of pre-malignant or malignant lesion in healthy before the end of follow-up period, the second Pantum detect test is performed at the time of its diagnosis. Therefore, the duration of inclusion for healthy controls is 12 months.

Diagnostic Test: Pantum detect test

Interventions

Pantum detect test DIAGNOSTIC_TEST

epitope detection in monocyte (EDIM)

Also known as: FDG PET/CT

Cancer Group; Control Group

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this trial, an individual must meet all the following criteria:
• Group A
• Suspected or confirmed macroscopic solid pre-malignant or malignant lesion(s)
• Availability of result of FDG PET/CT performed -30 to-15 days or up to +30 days from trial intervention and performed as a standard of care
• Willingness to undergo trial intervention
• Signed informed consent

You may not qualify if:

• Willingness to undergo trial intervention
• Signed informed consent
• An individual who meets any of the following criteria will be excluded from participation in this trial: For Group A and B
• Steroid-, chemo-, radio therapy in last 8 weeks
• Immunesuppression using following active ingredients; Methotrexate, Cyclosporine, Azathioprine, Tacrolimus, Mycophenolate, Rapamycin, Sirolimus, Mycophenolat-Mofetil in last 8 weeks.
• Granulocyte-Macrophage Colony-Stimulating Factor (GM-SCF); Molgramostim, Sargramostim in last 8 weeks o Amygdalin (Vitamin B17) in last 4 weeks
• Immune modulation using Corticosteroids, Glucocorticoids and Colchicine (Cortison/hydrocortisone \>5 mg/day, Budesonid \>5 mg/day) in last 4 weeks
• Antibiotics and Antifungals in last 2 weeks
• Vaccination: any vaccination in last 4 weeks.
• Infection: Acute Bacterial, Viral infection and Fungal infection in last 2 weeks.
• Imaging Investigation using contrast medium in last 2 weeks.
• Dialysis on the day of blood draw.
• Genetic disorder such as thrombocytopenia may leads to rejection of test due to reduced amount of Blood Cells.
• For Group B only:

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

Department of Nuclear Medicine

Bratislava, Slovakia

RECRUITING

MeSH Terms

Conditions

Precancerous Conditions

Condition Hierarchy (Ancestors)

Neoplasms

Central Study Contacts

Soňa Balogová, prof. MD PhD.

CONTACT

+421 2 59 77 72 90; sona.balogova@fmed.uniba.sk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PanTum Detect is a multi-tumour screening blood test for the presence of silently growing malignant or pre-malignant lesions. PanTum Detect is an Epitope Detection in Monocytes/Macrophages (EDIM) based test technology uses the information contained in the human immune system for detection of pre-malignant or malignant lesions. Higher than normal levels of Apo10 (DNaseX) \& transketolase-like protein 1(TKTL1) detected in macrophages of examined individuals gives an indication of potential pre-malignant or malignant lesions. The test has an In Vitro Diagnostic (IVD) CE certified specificity of 99% and sensitivity of 97.5%.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: February 24, 2025
• Study Start: May 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)