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Diagnostic Performance of [68Ga]Ga-HKG301 PET/CT with FAP-2286 in Patients with Pancreatic Adenocarcinoma and Invasive Lobular Breast Cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study looks at two types of cancer: Pancreatic adenocarcinoma and Invasive lobular breast cancer. It uses a new imaging agent called AAA514, which contains the substance FAP-2286. The agent is given through an IV (a needle placed into a vein) and then a special scan called PET/CT is performed. The PET/CT scan combines a camera that detects a tiny amount of radioactivity with a CT scanner that creates detailed pictures of the inside of the body, helping doctors see if cancer has spread to lymph nodes or other organs.

The purpose of the study is to find out how well this new scan can detect cancer spread compared with standard imaging. Participants may have a blood test for CA19-9 (a marker that can be high in pancreatic cancer) or tumors with a HER2-positive pattern (a specific protein on breast cancer cells). After the IV injection, the scan is done a short time later, and doctors review the images to see whether the information changes the planned treatment. The study follows each participant for a brief period to collect the scan results and compare them with other tests.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments

    You will undergo a blood test to measure the level of CA19‑9, a protein that can be high in pancreatic cancer.

    Your medical records and any recent conventional imaging studies will be reviewed to confirm eligibility for the trial.

  2. Step 2

    Radiopharmaceutical Preparation

    A radiopharmaceutical called [68Ga]Ga‑HKG301 (active substance fap‑2286) will be prepared in a sterile kit.

    The preparation is performed by qualified pharmacy staff according to strict safety standards.

  3. Step 3

    Injection of the Study Drug

    You will receive a single intravenous (IV) injection or infusion of 300 MBq (megabecquerels) of [68Ga]Ga‑HKG301.

    The dose is administered once, and the administration takes only a few minutes.

  4. Step 4

    Uptake Period

    After the injection, you will wait for the tracer to circulate and bind to target tissue, usually about one hour.

    During this time you may sit or lie comfortably in a quiet area.

  5. Step 5

    PET/CT Scan

    A combined positron emission tomography (PET) and computed tomography (CT) scan will be performed.

    The scanner creates detailed images that show the distribution of the radiopharmaceutical in the pancreas or breast and any possible spread of disease.

  6. Step 6

    Image Review and Staging

    The imaging results will be evaluated by the responsible clinician to determine the presence of regional or distant metastases.

    The assessment will compare the new PET/CT findings with any prior imaging to decide on the most accurate stage of the cancer.

  7. Step 7

    Follow‑Up Consultation

    You will meet with the clinician to discuss the scan results and how they may affect your treatment plan.

    No further study medication is required after the single injection.

Who can join the trial?

6 criteria

  • You are 18 years or older, have a suspected or confirmed diagnosis of pancreatic adenocarcinoma with a tumor that doctors think can be removed by surgery, and your blood test shows a CA19-9 level higher than 500 units, or standard scans did not give clear results.
  • You are a woman 18 years or older with a confirmed diagnosis of invasive lobular breast cancer that has an unfavorable receptor status (either HER2‑positive or estrogen receptor less than 10%), or the cancer is at clinical stage II (tumor size T2 or larger) or stage III.
  • You have already had, or are planning to have, the standard initial staging scans that include contrast‑enhanced CT (ceCT), MRI, and a special PET/CT scan that uses a tracer called [¹⁸F]FDG.
  • You have signed a free written consent form agreeing to join the study.
  • You are willing to follow all study procedures and can be available for the entire duration of the trial.
  • Your overall health allows an ECOG performance status of 2 or lower, meaning you are fully active or able to carry out most daily activities.

Who cannot join the trial?

6 criteria

  • Pregnancy or breastfeeding – being pregnant or feeding a baby, which can affect the test.
  • Medical or psychiatric conditions that make it hard to understand the study and give consent – serious health or mental problems that prevent you from understanding and agreeing.
  • Any psychological, family, social, or travel issues that could stop you from following the study schedule – problems at home, work, or distance that make it difficult to attend visits.
  • Significantly reduced kidney function (creatinine clearance less than 60 mL/min) – your kidneys do not filter waste well enough; creatinine clearance is a test that measures kidney performance.
  • Known allergy (hypersensitivity) to the radioactive tracer or any part of the HKG301 drug – you have had a reaction to similar substances before.
  • Unable to have a PET/CT scan (for example, severe fear of small spaces, weight over the scanner limit, or cannot stay still lying down) – you cannot tolerate the imaging procedure.
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Investigated drugs

AAA514 is a special diagnostic medicine that contains a tiny amount of a radioactive substance called FAP‑2286. It is made to attach to a protein that many tumors have, helping doctors see those tumors more clearly on a PET/CT scan. In the trial, the medicine is prepared from a kit and given to patients through an IV injection or infusion. After it is injected, the patient undergoes a PET/CT scan, which creates detailed pictures of the pancreas or breast tissue. This helps doctors determine how the cancer looks, whether it might be removed by surgery, and how aggressive it may be. The medicine does not treat the cancer; it only helps with diagnosis and planning of care.

What is already known about the treatment

FAP-2286 - This investigational radiopharmaceutical is supplied as a kit that is prepared for an intravenous injection or infusion, delivering a measured amount of radioactivity (300 MBq). It is currently being studied in clinical trials and is not yet approved for routine medical use. The tracer is designed to help doctors see pancreatic adenocarcinoma and invasive lobular breast cancer during PET/CT scans by attaching to a protein called fibroblast activation protein that is often found on tumor‑associated cells. It belongs to the class of PET imaging agents known as fibroblast activation protein inhibitors, working at the molecular level to emit a signal that the scanner can detect.

Investigated diseases

  • Pancreatic adenocarcinoma

    It is a cancer that starts in the glandular cells of the pancreas. It usually originates in the part of the pancreas that produces digestive enzymes. As it enlarges, it can invade nearby blood vessels and lymph nodes and later spread to the liver, lungs, or peritoneal cavity. The tumor may block the pancreatic duct, causing digestive difficulties. Blood levels of CA19‑9 often rise as the disease advances.

  • Invasive lobular breast cancer

    It is a breast cancer that begins in the milk‑producing lobules and then infiltrates surrounding breast tissue. The cancer cells often grow in single‑file rows, giving the tumor a softer feel than other breast cancers. Over time it can involve the lymph nodes and travel to distant sites such as bone, lung, or abdomen. Hormone‑receptor patterns may shift as the disease progresses, and the tumor can become larger and involve more of the breast.

Trial detailsLast updated 3 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-526498-40-00Protocol codeCAAA514A1AT01TEstimated enrolment60 patientsSponsorGemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH

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