PanTum Detect blood test for adults with suspected or confirmed solid pre-malignant or malignant lesions and healthy controls referred for FDG PET/CT

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

This project will test whether the PanTum Detect blood test can find pre-malignant or malignant solid lesions in adults referred for FDG PET/CT and in healthy adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years to 88 Years
• Sex: All
• Sponsor: Comenius University (Academic / other)
• Drugs / interventions: Methotrexate
• Locations: 1 site (Bratislava)
• Trial ID: NCT06842615 on ClinicalTrials.gov

What this trial studies

This prospective phase II diagnostic study will test the PanTum Detect EDIM blood assay, which measures Apo10 and TKTL1 in monocytes, in two parallel groups: adults with suspected or confirmed macroscopic solid pre-malignant or malignant lesions referred for FDG PET/CT (Group A) and healthy adult controls (Group B). About 67 participants are planned per group; participants in Group A will have the test at inclusion and, if lesions are only suspected, again after a 12‑month follow-up, with results compared against standard-of-truth imaging, pathology and clinical follow-up. Primary outcomes are diagnostic sensitivity and specificity, and the trial will prospectively examine the test’s performance in the intended clinical population. The protocol requires PET/CT results within defined windows and blood sampling per the test manual and site procedures.

Who should consider this trial

Good fit: Ideal candidates are adults 18–88 years old with suspected or confirmed macroscopic solid pre-malignant or malignant lesions referred for FDG PET/CT, and healthy adults without known lesions willing to serve as controls.

Not a fit: People with acute illness, recent surgery, organ transplantation, certain comorbid conditions listed in the exclusion criteria, or those outside the 18–88 age range are unlikely to benefit from participation.

Why it matters

Potential benefit: If validated, the test could provide a non-invasive blood tool to flag people who need earlier diagnostic work-up and potentially enable earlier treatment.

How similar studies have performed: Manufacturer-reported CE-marked IVD data indicate high sensitivity (~97.5%) and specificity (~99%), but prospective independent clinical data in routine referral populations are limited.

Eligibility criteria

Inclusion Criteria:

To be eligible to participate in this trial, an individual must meet all the following criteria:

Group A

* Age 18-88 years at inclusion (Man, Woman)
* 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
* Absence of any of exclusion criteria Group B
* Age 18-88 years at inclusion (Man, Woman)
* Considered as free of pre-malignant or malignant lesion(s) at the time of inclusion
* Willingness to undergo trial intervention
* Signed informed consent
* Absence of any of exclusion criteria

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this trial: For Group A and B

1. Acute Illness, Organ Transplantation, Surgeries, and injuries are an exclusion criteria: e.g. bone fracture, deep cut (deeper 0.5 cm and/or larger than 1 cm), abrasion (greater than 5 cm in diameter), open wound, contusion, torn ligaments, blood in the stool, blood in the urine. After successful recovery the waiting period must be 8 weeks.
2. Medication: Any treatment or activity that could impact the immune system must be considered as an exclusion criteria.These includes.

   1. Steroid-, chemo-, radio therapy in last 8 weeks
   2. Immunesuppression using following active ingredients; Methotrexate, Cyclosporine, Azathioprine, Tacrolimus, Mycophenolate, Rapamycin, Sirolimus, Mycophenolat-Mofetil in last 8 weeks.
   3. Granulocyte-Macrophage Colony-Stimulating Factor (GM-SCF); Molgramostim, Sargramostim in last 8 weeks o Amygdalin (Vitamin B17) in last 4 weeks
   4. Immune modulation using Corticosteroids, Glucocorticoids and Colchicine (Cortison/hydrocortisone \>5 mg/day, Budesonid \>5 mg/day) in last 4 weeks
   5. Non-Steroidal anti-inflammatory drugs (NSAIDs) \& CGRP including in last 2 weeks. An occasional use of Ibuprofen, Paracetamol and Aspirin is not an exclusion criteria.
   6. Antibiotics and Antifungals in last 2 weeks
3. Vaccination: any vaccination in last 4 weeks.
4. Infection: Acute Bacterial, Viral infection and Fungal infection in last 2 weeks.
5. Imaging Investigation using contrast medium in last 2 weeks.
6. Dialysis on the day of blood draw.
7. Genetic disorder such as thrombocytopenia may leads to rejection of test due to reduced amount of Blood Cells.

For Group B only:

1\. Previous and Current Cancer: In case of previously diagnosed and successfully treated Tumour \& cancer, the PanTum Detect test should be done 5 years after the successful treatment \& cure. This applies to all kind of Tumour and Cancers. all currently ongoing cancer treatments and newly diagnosed cancer including ongoing diagnostic procedures are an exclusion criterion

Where this trial is running

Bratislava

• Department of Nuclear Medicine — Bratislava, Slovakia (Recruiting)

Study contacts

• Study coordinator: Soňa Balogová, prof. MD PhD.

Conditions Pre-malignant; Malignant; macroscopic; solid lesion; pre-malignant; malignant lesion