Cracking the Code of Solid Tumor Imaging in Clinical Trials

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When it comes to clinical trials for solid tumors, imaging plays a crucial role in assessing treatment efficacy and monitoring disease progression. However, the process is often more complex than it appears at first glance. This complexity arises from various factors that can affect the accuracy and reproducibility of imaging results.

Without the right insight and expertise, clinical trials risk inefficiencies, missed endpoints, and delayed approvals. In this blog, we explore why solid tumor imaging can be challenging in clinical trials, using three examples: breast cancer, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC), and discuss the importance of partnering with the right imaging provider.

Non-Small Cell Lung Cancer (NSCLC)

At first, imaging in NSCLC trials might seem straightforward, especially with the use of RECIST (Response Evaluation Criteria in Solid Tumors) guidelines.

However, several factors can complicate the clinical trial imaging process:

1. Adjuvant Therapy Post-Tumor Resection: After surgical removal of the tumor, adjuvant therapies can introduce changes that make it
   difficult to assess the tumor accurately.
2.  Post-Radiation Fibrotic Changes: Radiation therapy can cause fibrotic changes in the lung tissue, which can interfere with the reproducibility of imaging assessments.
3. On-Study Interventions: Clinical trial interventions can affect the consistency of imaging results, making it challenging to track tumor progression or response to treatment.
4.  Tumor Growth Leading to Atelectasis: Tumor growth can cause atelectasis (collapse of lung tissue), which complicates the reproducibility of imaging assessments.
5. Adrenal Gland Enlargement: Enlargement of the adrenal glands can be mistaken for metastasis, or new adrenal gland changes may not be considered metastatic, adding to the complexity of accurate imaging.

Breast Cancer (BCa)

Breast cancer imaging also presents unique challenges in clinical trials, despite the use of RECIST guidelines:

1. Adjuvant Therapy and Lymph Node Dissection: After tumor resection and lymph node dissection, distinguishing between new metastatic lesions and non-tumor-related pathology can be difficult.
2. Initial Metastases in the Skeleton: Up to 60% of early-stage breast cancer patients may develop initial metastases in the skeleton. This necessitates the use of appropriate and widely accepted imaging methods throughout clinical trials, such as WB-MRI, X-Ray Skeletal Survey, SPECT, 18F-PET, and 99m Tc Bone Scan.
3. Imaging Modality Considerations: Deciding whether Breast MRI or Mammography should be acceptable imaging modalities in a trial is crucial. Additionally, the inclusion of patients with brain metastases and whether these metastases should be selected as target lesions (TLs) or non-target lesions (NTLs) adds another layer of complexity

Renal Cell Carcinoma (RCC)

Imaging RCC is particularly challenging in clinical trials due to the following reasons:

1.  Adjuvant Therapy Post-Nephrectomy: After the surgical removal of the kidney (nephrectomy), distinguishing between new metastatic lesions and non-tumor-related pathology, such as reactive versus metastatic lymph nodes or benign versus malignant small lung nodules, can be difficult.
2. Post-Surgical Changes: Post-surgical adhesions and fibrotic scars in the renal bed can be mistaken for tumor recurrence.
3. High Percentage of Skeletal Metastases: Similar to breast cancer, RCC patients often develop skeletal metastases. Appropriate imaging methods, such as WB-MRI, X-Ray Skeletal Survey, SPECT, 18F-PET, and 99m Tc Bone Scan, must be considered and accepted throughout clinical trials.

 The Importance of Imaging Core Lab’s Expertise

Navigating these complexities requires a deep understanding of clinical trial imaging techniques and limitations. Perceptive’s imaging core lab is well- versed in the nuances of solid tumor imaging and can provide the necessary insights to ensure your clinical trials are conducted efficiently and accurately. By leveraging our expertise, you can avoid the pitfalls that lead to inefficiencies, missed endpoints, and delayed approvals.

Interested in speaking to our Scientific & Medical Services team? Get in touch today.