Phase 2 Breast Cancer Trial, Not Yet Recruiting NCT04480619 Sponsor: Advanced Imaging Projects, LLC Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Not Yet Recruiting

NCT04480619
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have a solid tumour that tests positive for a specific protein marker (either strongly positive on an immunohistochemistry test, or showing gene amplification on a FISH test).
  • People who are at least 18 years old.
  • People who are able to give their informed consent to take part.
  • People who have a Karnofsky performance score above 50, which means they are able to carry out some daily activities with some assistance at minimum (confirm with trial site).
  • Women who could become pregnant must have a negative pregnancy test at the start of the study.
  • People who have a positive scan result using AIP-301 Ga-68, with a specific measurement (SUV) greater than 10.
  • People whose blood counts meet the required levels: white blood cells (neutrophils) at or above a set level, haemoglobin at or above 9 g/dL (blood transfusions or supportive medication are allowed), and platelets above 100,000/mm³.
  • People whose kidney function is within an acceptable range based on a standard calculation.
  • People whose liver enzyme levels (AST or ALT) are within acceptable limits, with slightly higher levels allowed if liver spread of cancer is present.
  • People whose alkaline phosphatase (a liver and bone enzyme) is within acceptable limits, with an exception allowed if bone spread of cancer is present alongside normal-range liver enzymes.
  • People whose total bilirubin (a liver marker) is at or below 1.5 mg/dL, with higher levels allowed for people who have a condition called Gilbert's syndrome.
  • People whose heart pumping function (LVEF) is at or above 50%, as measured by an echocardiogram or a MUGA scan.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose blood creatinine level (a measure of kidney function) is above 3.0 mg/dL.
  • People whose liver enzyme levels are more than five times the upper limit of the normal range.
  • People who have a known severe allergy or hypersensitivity to contrast dye used in imaging scans.
  • People who have used another experimental treatment or device within the 30 days before the study begins, or who are known to need another experimental treatment during the study period.
  • People who weigh 400 pounds (approximately 181 kg) or more, or whose body size means they are unable to fit into the PET/CT scanner, as this would affect the quality of the images.
  • People who are unable to lie still for the full duration of the imaging scans (for example, due to a persistent cough or severe arthritis).
  • People who are unable to complete the required imaging tests for other reasons, such as severe claustrophobia or a fear of radiation.
  • People who have a currently active recognised infection, such as HIV.
  • People who have previously had a severe (Grade 3 or higher) allergic reaction to the drug Trastuzumab that led to that treatment being stopped.
  • People who have any other medical condition or serious illness that, in the opinion of the study investigator, may significantly affect their ability to take part in the study safely and fully.
  • Adults who would need sedation or anaesthesia in order to undergo a PET scan.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 24 July 2026

Contact this trial

Phone: 561-561 286-6842

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Advanced Imaging Projects, LLC
Registry
ClinicalTrials.gov
Start date
30 October 2025
Est. completion
30 May 2027

Where this trial is recruiting

🇮🇳 India 🇿🇦 South Africa

Primary endpoints

Specific Aims 1:To evaluate the safety, toxicity profile and tolerability of Ga-68-IAC in patients diagnosed with angiogenic breast cancer.; Specific Aims 2:To evaluate biodistribution and dosimetry of Ga-68-IAC; Specific Aims 3: To determine the recommended phase 2 dose (RP2D) of Ga-68-IAC examination

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 24 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov