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New radioactive tracer could spot hidden tumors

NCT ID NCT05799274

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 15, 2026 · Updated 4 times

Summary

This early-stage trial tests a radioactive imaging agent called RAD301 in 9 people: healthy volunteers and patients with pancreatic, lung, esophageal, cervical, endometrial, or ovarian cancer. The goal is to see how safe it is and how it travels through the body. If it works, it might help doctors see tumors more clearly on scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RAD301 (a radioactive imaging agent)
What this could lead to
If successful, this could lead to a safer way to detect and monitor certain cancers using PET scans.
What could go wrong
This is a very early Phase 1 trial with only 9 participants, so results may not apply broadly. The main goal is safety, not effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 9 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Must be ≥ 18 years of age at the time of informed consent. 2. All participants must be willing and able to give informed consent. 3. For patients with cancer: have a history of histologically or cytologically confirmed PDAC, non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma, cervical cancer, endometrial cancer, or ovarian cancer and have had a SOC CT or MRI within 12 weeks prior to giving consent that indicates the presence of at least 1 site of new or residual disease. If the SOC CT or MRI has occurred prior to 12 weeks, consultation with the Sponsor must be sought prior to patient enrollment. SOC images must be available for submission to the centralized imaging reader as reference. 4. Screening laboratory values within 30 days prior to administration of the study drug: 1. WBC ≥ 1200/μL 2. ANC ≥ 1000/μL 3. Platelets ≥ 75,000/μL 4. Hemoglobin ≥ 9.0 g/dL 5. Creatinine ≤ 1.5 mg/dL 6. AST/ALT ≤ 3 x ULN for patients with no liver metastases. 7. AST/ALT ≤ 5 x ULN for patients with liver metastases. 8. Bilirubin ≤ 1.5 mg/dL except for participants with Gilbert's disease. 5. Patients should have a life expectancy of ≥ 12 weeks as judged by the Investigator. 6. All participants must have baseline pulse oximetry ≥ 95% on room air. 7. Unremarkable ECGs, with PR intervals of less than 200 msec and QTcF intervals (corrected with Frederica's method) of less than 450 msec. 8. Willing to refrain from taking illicit drugs one week prior to PET scanning and through the follow-up phone call on Day 3 (+2 days). 9. Willing to refrain from donating blood for 4 weeks after administration of RAD301. 10. Have not participated in any other research study that requires taking medication within 4 weeks (or 10 half-lives, whichever is shorter) from the time of informed consent to the end of the Imaging and Safety Follow-Up Period. Previous or ongoing participation in another study should be discussed with the Sponsor. Exclusion Criteria: 1. Participant may not be a member of a vulnerable population defined as participants who are not able to understand the nature of the trial and provide informed consent or who have any medical, psychological or sociological condition that in the opinion of the investigator would interfere with the ability to give consent or interfere with protocol compliance. 2. Women may not be pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to administration of RAD301. 3. History of an anaphylactic reaction to a protein- or peptide-derived therapeutic or a diagnostic agent. 4. History, physical examination, or clinical laboratory tests suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination of RAD301, including chronic liver or renal failure. 5. Unable to tolerate the study procedures. 6. Patients with brain metastases are eligible as long as there is no requirement for high doses of systemic corticosteroids that could result in immunosuppression (\>10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration. An MRI is not required to rule out brain metastases or leptomeningeal metastases 7. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results. 8. Clinically significant cardiovascular/ cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attach (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class \>II) or serious cardiac arrhythmia. 9. Other than the tumor types being studied, a prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast. 10. Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. 11. Participants who underwent major surgery within 4 weeks of administration of study drug (not including diagnostic laparoscopy).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • United Theranostics

    Princeton, New Jersey, 08540, United States

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Other studies related to the condition(s) this trial covers.