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PET [89Zr]DFO-starPEG Imaging in Solid Tumors

This study is testing a new imaging substance called [89Zr]DFO-starPEG. It's given through a vein (intravenously) and helps doctors see solid tumors and soft tissue lesions using a special scan called a PET scan (Positron Emission Tomography). Researchers want to see how well this substance is absorbed by tumors and how safe it is. You might be able to join if you are 18 or older and have a solid tumor that has been confirmed by a biopsy, with at least one measurable lesion. The main goal is to measure how much of the substance is taken up by tumors compared to surrounding tissues. The study is currently unclear about its recruitment status.

Study design
This is a pilot study, meaning it's a first-time test in humans, and plans to enroll 13 participants. It is an interventional study, where participants will be assigned to one of two groups.
What's involved
You will receive [89Zr]DFO-starPEG intravenously and undergo whole-body PET scans. You will also provide urine and blood samples. Depending on your group, you may have multiple scans over time or a single scan.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects for about one week after receiving the imaging substance, until a visit between 5 and 9 days later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06894745

PET [89Zr]DFO-starPEG in Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Robert Flavell, MD, PhD
~13 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:89-zr-dfo-star polyethylene glycol (StarPEG)Whole Body Positron Emission Tomography (PET)Specimen Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Median Maximum Standardized Uptake Value (SUVmax) by cohort
Measured over Up to 9 days
+3 more outcomes measured

Conditions

Solid Tumor
Solid Carcinoma
Soft Tissue Lesion

Explore related trials

Solid CarcinomaSolid Neoplasm

NCT06894745

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of California, San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Robert Flavell, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Maya Aslam
[email protected]
(415) 514-8987
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits) .
Aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 x ULN.
Alanine aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) ≤ 3 x ULN.
Estimated creatinine clearance: ≥ 60 mL/min, calculated using the Cockcroft-Gault equation or 24 hour urine collection. 7. Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \[89Zr\]DFO-starPEG. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries). The result of the urine or serum pregnancy test must be negative in order to initiate the \[89Zr\]DFO-starPEG administration. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \[89Zr\]DFO-starPEG. 8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible. 9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of \[89Zr\]DFO-starPEG.
A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries). 4. Hypersensitivity to \[89Zr\]DFO-starPEG or any of its excipients. 5. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.

What this trial measures

  • Median Maximum Standardized Uptake Value (SUVmax) by cohortUp to 9 days

    The median and range for intra-tumoral SUVmax within metastatic lesions will be descriptively reported, to assess for intra-tumoral heterogeneity and differences in uptake by site of disease.

  • Tumor-to-background signal ratio (muscle)Up to 9 days

    Adjusted SUVmax data will be averaged across up to 15 lesions within a given patient (SUVmax-avg). VOI will also be placed around the aortic blood pool and paraspinal musculature. Tumor to muscle SUV ratios will be calculated by dividing tumoral SUV by muscle SUV, respectively

  • Tumor-to-background signal ratio (blood)Up to 9 days

    Adjusted SUVmax data will be averaged across up to 15 lesions within a given patient (SUVmax-avg). VOI will also be placed around the aortic blood pool and paraspinal musculature. Tumor to blood SUV ratios will be calculated by dividing tumoral SUV by blood SUV.

  • Mean absorbed dose of PET [89Zr]DFO-starPEG (Cohort A)Up to 9 days

    Volumes of interest (VOIs) will be drawn around regions identified on the scans that exhibits clearly elevated uptake over the background. Time-activity curves will be generated for each organ, and curve-fitting will be performed to derive the time-integrated activity coefficients (TIACs, also known as residence times). TIACs will be entered into the OLINDA software. The results from all participants in the dosimetry cohort will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs as well as effective dose.