Trial · NCT07879547
Safety and Diagnostic Efficacy of 177Lu-AF03 in Patients With Solid Tumors
NCT07879547, Early phase 1, Not yet recruiting, Yong He
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Diagnostic Efficacy of 177Lu-AF03 in Patients With Solid Tumors. Trials, record NCT07879547. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07879547
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Diagnostic Efficacy of 177Lu-AF03 in Patients With Solid Tumors
- NCT number
- NCT07879547
- Status
- Not yet recruiting
- Phases
- Early phase 1
- Enrollment
- 8 participants, estimated
- Lead sponsor
- Yong He
- Conditions
- Malignant Solid Tumors, Neoplasms
- Interventions
- 177Lu-AF03
- First posted
- 2026-10-19
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and Severity of Adverse Events and Serious Adverse Events | Baseline through 1 month post-injection | Number of participants with adverse events and serious adverse events graded according to CTCAE v5.0 criteria from dosing through 1 month post-injection. |
| Primary | Organ Absorbed Dose of 177Lu-AF03 | Up to 168 hours post-injection | Organ absorbed doses (mGy/MBq) will be estimated from serial SPECT/CT imaging data using OLINDA software. Regions of interest will be drawn for major source organs to determine time-integrated activity coefficients. |
| Primary | Biodistribution of 177Lu-AF03 in Major Organs | Up to 168 hours post-injection | Biodistribution of 177Lu-AF03 will be assessed using serial SPECT/CT images. Regions of interest will be drawn for major organs (liver, kidney, spleen, red marrow, urinary bladder, and whole-body background) to determine radioactive retention (%ID/g or %ID/organ) at multiple time points post-injection. |
| Primary | Whole-Body Effective Dose of 177Lu-AF03 | Up to 168 hours post-injection | Whole-body effective dose (mSv/MBq) will be estimated from serial SPECT/CT imaging data using OLINDA software. |
| Secondary | Semi-Quantitative Assessment of Tumor Uptake Using Standardized Uptake Value | Up to 168 hours post-injection | 177Lu-AF03 SPECT/CT images will be reconstructed using the ordered subset expectation maximization method with attenuation and scatter correction. Regions of interest will be drawn around tumor lesions to calculate standardized uptake values (SUV) as a semi-quantitative measure of tracer accumulation. |
| Secondary | Qualitative Assessment of Tumor Uptake by Visual Analysis | Up to 168 hours post-injection | 177Lu-AF03 SPECT/CT images will be independently reviewed by two experienced nuclear medicine physicians blinded to other clinical data. Positive tumor uptake is defined as focal or diffuse increased tracer accumulation above surrounding normal tissue, after excluding physiological uptake in normal organs and tissues. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07879547
GET https://conductscience.org/api/trials/v1/NCT07879547/registered