CompletedPhase 1

A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoCAIX in Patients With CAIX-positive Cancer

Italy20 participantsStarted 2025-04-16

Plain-language summary

Phase I and multicenter study to evaluate the safety and dosimetry of 68Ga-OncoCAIX in patients with clear cell renal cell carcinoma.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with suspected ccRCC (based on standard diagnostic workup).
. Requirement for diagnostic imaging or diagnostic imaging recently performed.
. For female patients: negative serum pregnancy test for women of childbearing potential\* (WOCBP). WOCBP must agree to use, from the screening to six months following the study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone only or combined hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.
. For male patients: Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.
. Age ≥ 18
. ECOG ≤ 1
. Patient must not have any concomitant infections or active concomitant disease.
. All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 5.0) Grade ≤ 1.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cohort A: Dosimetry - Effective dose equivalent (mSv)

Timeframe: Assessed on day 1

Cohort A: Dosimetry - Effective dose absorbed doses (mGy)

Timeframe: Assessed on day 1

All patients: Safety (AEs and SAEs)

Timeframe: Throughout the study, until a maximum of 7 days after the administration of the study drug.

Trial details

NCT IDNCT06840548

SponsorPhilogen S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-28

View on ClinicalTrials.gov More Clear Cell Renal Cell Carcinoma (ccRCC) trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with suspected ccRCC (based on standard diagnostic workup).
. Requirement for diagnostic imaging or diagnostic imaging recently performed.
. For female patients: negative serum pregnancy test for women of childbearing potential\* (WOCBP). WOCBP must agree to use, from the screening to six months following the study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone only or combined hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.
. For male patients: Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.
. Age ≥ 18
. ECOG ≤ 1
. Patient must not have any concomitant infections or active concomitant disease.
. All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 5.0) Grade ≤ 1.

Exclusion criteria

What they're measuring

Cohort A: Dosimetry - Effective dose equivalent (mSv)

Timeframe: Assessed on day 1

Cohort A: Dosimetry - Effective dose absorbed doses (mGy)

Timeframe: Assessed on day 1

All patients: Safety (AEs and SAEs)

Timeframe: Throughout the study, until a maximum of 7 days after the administration of the study drug.