Clinical trial · Interventional
Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study)
NCT05823402CI-TRIAL-00066131SPECTacularunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The SPECTacular study will enroll patients who are already undergoing a FDA approved PSMA-targeted Radioligand treatment cycle. During each treatment cycle, patients will receive 5 additional SPECT/CT scans to investigate the limits of agreement between dosimetry (absorbed radiation dose) approximation methods and dosimetry using the triexponential fitting method.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPECT/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SPECT/CT
- description
- All patients enrolled will undergo 5 additional (6 total) SPECT/CT scans per treatment cycle. Current FDA approved PSMA radioligand therapy is administered over 6 cycles, so there will be a total of 30 additional SPECT/CT scans during this study. During each treatment cycle, patients will have a SPECT/CT scan at the following time points after administration of PRLT: * 4 Hours * 24 Hours (+/- 8 Hours) * 48 Hours (+/- 8 Hours) * 96 Hours (+/- 8 Hours) * 168 Hours (+/- 24 Hours) * 336 Hours (+/- 24 Hours)
- interventionNames
- Diagnostic Test: SPECT/CT
Primary outcomes (1)
- measure
- Dosimetry Method
- timeFrame
- Immediately after the completion of SPECT/CT scanning.
- description
- To determine the limits of agreements between dosimetry approximation methods and dosimetry using the triexponential fitting method.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male, 18 years old or older 4. Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component. 5. Patient is receiving PSMA-targeted Radioligand Therapy (PRLT) for treatment of PSMA-positive tumor and/or metastases of prostate cancer. Therapy may be FDA approved or investigational in nature under an approved clinical trial. 6. Ability to lay flat on scanner for duration of SPECT-CT imaging studies (1-2 hours) Exclusion Criteria: 1. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol. 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2 3. All criteria which may preclude a PSMA-radioligand therapy using Lu-177 PSMA-617 or Lu-177 PSMA I\&T to be performed as per standardized guidelines and protocols laid down for these treatments and per decision by the treating physician.
References
Publications (0)
Data not yet available
No reference posted for this study.